Tag: sotera health

US FDA Consultants

Posted on by Joby Semmler

Our US FDA Consultants Understand the Life Science Industry

 

Regulatory Compliance Associates (RCA) provides US FDA consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:

 

Life Science consultants

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

sotera healthSotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Regulatory Compliance Associates Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading US FDA consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every step of the FDA consulting process. Our FDA 510k consultants will create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our FDA regulatory consultants span all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your FDA regulatory consulting services partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep by FDA consulting firms could mean significant and lasting consequences for client revenue and industry profitability. At Regulatory Compliance Associates, we offer the experience and FDA compliance consultants necessary to guide you in quality compliance.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation 

 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA® can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Regulatory Compliance Associates Medical Device Consulting Services

 

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA®‘s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 life science consultants — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® ‘s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA 510k consultant experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

 

Our network of over 500 FDA, Health Canada & MHRA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates®‘s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA®, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500 industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Waterfall Methodology

Posted on by Brandon Miller

Click now to watch Regulatory Compliance Associates® Dr. Stephen Coulter explain how design controls and risk management play an intricate role in the Waterfall methodology:

 

 

The Waterfall methodology incorporates the usage of FDA design controls into the medical device design process. It serves as the primary connection between quality system requirements (QSR) and current good manufacturing practices (CGMP).

 

Waterfall Method

 

Conceptually, the FDA Waterfall model is designed to provide engineers with the flexibility to mitigate product risk, meet regulatory compliance and satisfy customer needs. It is a sequential process based on the quality assurance and medical device engineering principles listed in 21 CFR 820. The methodology itself is conceptualized in the image below from the Medical Device Bureau of Health Canada. 

 

Waterfall Development

 

waterfall methodologyTo increase risk mitigation during the Waterfall methodology, both risk management & design controls are considered. They often become integrated processes during Waterfall product development. Many unique tools that medical device engineers use to define requirements & meet user needs are shared across these processes, even though each is based on a separate standard.

 

While design controls for FDA approval are referred to in 21 CFR 820, medical device risk management is internationally associated with ISO 14971. Three critical elements of risk mitigation strategies clearly focus on avoiding risk during product development:

 

  • Evaluating an associated risk
  • Controlling an evaluated risk
  • Monitoring risk control effectiveness overall

 

Input Requirements

 

The success of the Waterfall development method depends on early research & assessments conducted about input requirements that include strategic risk. Further, spending time documenting the inputs of user interface, user stories and product epics can help increase positive outcomes and reduce requirement risk overall.  Finally, any inconsistencies during the waterfall methodology between the proposed design & input requirements can be corrected across stages. This aligns with one of the primary motivations behind FDA originally developing 21 CFR 820 (e.g. helping medical device manufacturers find design deficiencies earlier in the process).

 

Risk Management

 

By starting the Waterfall process with this end state in mind, design inputs are more likely to pass failure testing & become a manufacturing output. This risk management strategy during a Waterfall project can begin with identifying the publicly known risks of competitive products. Second, the team is challenged to investigate if similar hazards could be associated with your medical device. When working with a Regulatory Compliance Associates risk management consultant, our clients are reassured that Waterfall development should detail how hazards can impact user needs & potential customers.

 

For example, design inputs should consider current regulations and global standards early in the waterfall process. This helps incorporate a risk management perspective even before verification and validation testing begins. Intended uses should consider predicate devices and if any causes for recalls are related to design, materials, or software. 

 

Waterfall Approach

 

So, does this mean risk management & design controls are connected in the waterfall approach? And if they are, how important is one over the other when leading to marketing approval or regulatory compliance? This process is often measured against a combination of factors, including:

 

  • Regulations & standards for clinical approval
  • Risk class of medical device being manufactured
  • Regulatory body reviewing the marketing submission

 

Enterprise risk management would consider all three of these factors individually and in combination when considering how to eliminate systemic risk. The Waterfall project management team can also use various tools and techniques while developing the risk management plan. These risk identification tools include conducting a risk analysis, performing an FMEA, and charting risk tolerance. 

 

Risk Analysis

 

Existing regulations & standards offer various types of risk tools that can be incorporated into design controls. This can include identifying risk levels and creating severity charts during the user needs & design inputs stages. Additionally, each new product will have different hazards and risk tolerance levels associated with the target patient. Being able to analyze the problem, control the problem, and mitigate the risk is essential to define in your risk analysis. Challenge yourself to reduce and identify hazards by analyzing the known data as much as possible.

 

FMEA

 

Failure Mode and Effects Analysis (FMEA) is a controlled technique to detect & concentrate on budding trouble. Each failure is commonly assigned a rating based on the negative effect it may cause. The Waterfall process would then take each rating and project how the marketplace, healthcare systems, or patients can be impacted. FMEAs are one of many risk mitigation tools that can help your team identify the hazards of your severity chart. Each charted hazard is established based on the severe nature of the hazard to the user and project requirements for design control.

 

Risk Tolerance

 

Further, after the severity is defined, all known or projected hazards can be developed into a risk tolerance chart. The risk tolerance chart can then be shared cross-functionally across the team to help everyone understand which design steps can increase user risk. One of the benefits of a risk tolerance chart is being able to show data visualization. The design team should consider how design controls and user needs can reduce the hazard’s impact. Finally, a waterfall chart could also project the negative consequences of adverse events and what the estimated cumulative impact might be during a product crisis scenario.

 

Risk Management Summary

 

Finally, once your team has evaluated the risks and decided on precautions, a risk management summary is developed. It may include involves multiple failure mode analysis types (e.g. product, process, etc.) and risk ratings. These initial ratings are typically based on the types of failures and the severity of the failure itself. Ranges can also be given to determine the risk management strategy and what is the acceptable level of product risk (e.g. high, medium, low).

 

About RCA’s Medical Device Consulting Services

 

medical device consultantThe regulatory process surrounding the medical device industry involves strict adherence to pre/post-market compliance throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates® medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consultant Experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates® works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483s, import bans, or consent decrees. Very few medical device consulting companies have the same expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates® medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates®, we offer a wide variety of services for medical device security to help ensure that your product is protected from cyber-attacks. With a well-planned waterfall methodology design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates® medical device consultant Experts can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission services involved with medical technology consulting.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our medical device regulatory consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the medical device consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or a project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts who are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA®

 

medical device consultantsRegulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health®

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

sotera healthSotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

MDR Updated Deadlines

Posted on by Brandon Miller

IVDR

 

Click now to listen to RCA’s Director of Regulatory Affairs, Jordan Elder, in this RCA Radio audio update about Medical Device Regulation, or MDR:

 

 

The European Parliament voted for a timeline extension in 2023 to MDR regulation, including an extended timeline for medical device regulatory submission. The 537-3 vote by members of the official body provides a final approval to extend MDR deadlines for compliance. Included in the legislation is revisions to regulatory submission rules for certifying medical devices. Additionally, the timeline includes new dates for both Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

 

Regulatory Agencies

 

European officials extended the MDR regulation to include legacy devices with existing certificates under the MDD to stay on the market until 2024. Industry executives have suspected for some time that the EU MDR backlog of submissions would lead to a slower process of legal regulation. Equally important, many EU health ministers voiced their opinion during a December 2022 session medical device shortages would occur without a MDR timeline extension.

 

MDR Timeline

 

Manufacturers now have until 2027 or 2028 to have medical devices certified and approved under MDR guidelines & regulation law. The timeline includes new dates for both high-risk medical device products and low risk medical devices. For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to:

 

  • 31 December 2027 for Class III and IIb;
  • 31 December 2028 for Class IIa and I.
  • 26 May 2026 for Class III implantable custom-made devices

 

The original “sell-off’ date requirement that was required under the MDR has been removed

 

Need help with your MDR or IVDR transition? Talk to our Experts →

 

IVDR Timeline

 

Meanwhile, the EU Commission has previously recommended the IVDR application date be extended due to the EU notified body bottleneck.

 

  • General EU MDR Class 1 Low-risk devices that are non-measuring, non-sterile, non-reusable, non-surgical, and that do not require review from a notified body will still go into effect in 2022.
  • Non-sterile Class A and B Devices (low risk) – May 26, 2022
  • Class D (Highest Risk) – May 26, 2025
  • Class C (Medium Risk) – May 26, 2026
  • Sterile Class A and B Devices (low risk) – May 26, 2027

 

Industry Reaction

 

Life science media outlets have reported extensively on the change since it was proposed at the meeting.

 

Stella Kyriakides, the European health commissioner, first proposed postponing the current MDR deadline dates during the EPSCO council meeting in Brussels. The health commissioner projected around 23,000 devices and 1,500 IVDs are currently approved and certified under MDD, but have not yet transitioned to the new MDR regulation. These medical devices are likely to expire in 2024 and 2025,

 

“The transition to the new rules has been slower than we anticipated,” said Kyriakides. “The pandemic, shortages of raw materials caused by the Russian invasion against Ukraine and low notified body capacity has put a strain on market readiness.”

 

Medical Device Manufacturers

 

Additionally, many unique viewpoints have emerged about the current landscape and the impact of recertification.

 

“If the three-year deadline is truly unattainable, these extensions could prevent devices that are perfectly safe for use from being taken off the market because they were unable to get recertified in time,” said Alexandra Murdoch, a medical analyst at GlobalData.

 

Murdoch added both medical device manufacturers and suppliers must now deliver MDR regulatory documentation for market approval, including data about materials used in medical device manufacturing.

 

Medical Device Safety

 

Both Pinto & Rocha have documented the MDR proposal concerns that “only medical devices considered safe will benefit from the extension”. This includes medical device manufacturers that have begun the process of submission and certification under the MDR.

 

Further, the Commission has recognized the ongoing need for patient safety and proposed a 2023 pilot project for medical device manufacturers. For example, expert panels to advise manufacturers with qualified scientific advice about devices that help treat rare diseases.

 

Medical Device Shortage

 

Ireland’s minister of health, Stephen Donnelly, supported the change based on COVID-19 procurement and preventing future medical device shortage scenarios.

 

“Participation in the EU COVID-19 vaccine strategy has allowed us to conduct the largest immunization program in our country’s history, saving countless lives and enabling the resumption of normal social and economic life.” said Donnelly.

 

“This measure needs to be adopted and take effect without delay to ensure that the devices our citizens and health systems rely on remain available.”

 

Cybersecurity

 

By contrast, it is still unknown how different types of EU legislation will regulate connected medical devices. There is concern across the industry about which legislation may take precedence and the level of postmarket surveillance data needed.

 

The European Commission (EC) published a proposal for a Cyber Resilience Act (“CRA”) to strengthen cybersecurity across medical device interoperability. Both Wright & Wenzel have documented this legislation does not consider MDR to impose as many obligations on medical device manufacturers. Further, the commentary suggests the EC may not require as much documentation about unknown vulnerabilities are not present for medical devices.

 

About RCA’s Medical Device Consulting Services

 

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates® medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consultant Experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates® works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. Very few medical device consulting companies have the same expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates® medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates® medical device consultant Experts can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission services involved with medical technology consulting.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our medical device regulatory consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the medical device consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

medical device consultantsRegulatory Compliance Associates (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

sotera healthSotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

AAPS PharmSci 360

Posted on by Brandon Miller

Regulatory Compliance Associates® will be exhibiting at AAPS PharmSci 360 in Orlando on October 22-25, 2023. Stop by booth #2210 to meet experts from each of our teams to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

 

About AAPS PharmSci 360

AAPS is a dynamic forum where you have access to cutting-edge research you can apply to your current science.

  • Stay on top of the latest scientific trends by attending sessions featuring presentations by leading researchers and experts
  • Review hundreds of scientific posters and see new research that can help you advance your work
  • Participate in Partner Presentations focused on practical science and best practices that can improve the efficiency of your organization
  • Enjoy bite-sized insights presented through the popular Rapid Fires and Speaker Spotlights

 

About RCA’s Pharmaceutical Consulting Services 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

  • 21 CFR 210
  • 21 CFR 211
  • Data Integrity
  • Computerized System Validation
  • Manufacturing Support
  • Facility Support

 

Remediation 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

regulatory complianceRegulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

regulatory complianceSotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

FDA Guidance: Continuous Manufacturing

Posted on by Joby Semmler

continuous manufacturingThe U.S. Food and Drug Administration (FDA) recently updated its pharmaceutical manufacturing guidance on Continuous Manufacturing (CM), including elaborating on established industry best practices.

 

Examples of new insights provided by FDA include clarification of the differences between continuous manufacturing modes and manufacturing approaches. The intended purpose behind the guidance is to continue industry harmonization efforts between ICH guidance and FDA regulatory & statutory requirements.

 

Continuous Manufacturing

 

Continuous manufacturing involves the process of uninterrupted materials being steadily added into the manufacturing process. The in-process ingredients are then manufactured and simultaneously developed into output materials during manufacturing. The updated FDA guidance focuses on facets of a continuous manufacturing system where multiple steps of operation are connected as continuous flow manufacturing.

 

The intended seamless procedure is considered by many industry experts as more efficient and helps reduce human error. By comparison, batch manufacturing lines may not use the same types of automated monitoring nor leverage as many predictive maintenance data points.

 

Factors of Production

 

The FDA guidance provides a deeper explanation of the underlying continuous manufacturing factors of production. A description of these characteristics by the Agency expands upon continuous flow production themes, including types of technology, options for dosage form, or molecule type.

 

Topics that are broadly applicable to a continuous production system and batch manufacturing are not included in the updated guidance scope. FDA recommends to the reader to revisit other existing ICH Q7 guidance as needed and appropriate for the medical manufacturer.

 

Control Strategy

 

Continued process performance and product quality are two primary elements described in the scientific approach to continuous manufacturing. State of control relies on the continuous production process and unique parameters (e.g. process parameters, quality attributes, etc.) that are designed to stay within an appropriate pre-set range.

 

Further, the guidance specifically calls out the importance of identifying the root cause of drift. FDA continuous manufacturing examples highlighted for employees to closely monitor include variation of inputs, equipment fatigue, and aging of materials.

 

Process Dynamics

 

Understanding transient events and the various impacts they can have on the continuous production system is a critical facet of FDA Control Strategy. Further, the FDA guidance elaborates that this includes transient events that are both planned (e.g., process start-up, process shutdown or a manufacturing pause) and unplanned (e.g. production disturbance).

 

Residence Time Distribution (RTD)

 

continuous manufacturingOne key takeaway from the FDA guidance for industry is understanding how process dynamics are characterized when output material quality is affected. Additionally, using measures like residence time distribution can help medical manufacturers differentiate between the time available for material transport and transformation. 

 

This type of quality metric strategy is specific to the continuous manufacturing process an often includes:

 

  • Product composition
  • Product formulation
  • Material properties
  • Equipment design
  • Equipment configuration

 

Operating Range

 

Each planned operating range should be based on the process dynamics and characterized by the planned over the planned ranges and anticipated input. Further, the FDA clearly states that material variability should use scientifically justified approaches for measuring quality against process dynamics that illustrate the variation during material transport and transformation.

 

Material Characterization

 

The FDA guidance goes on to list material feeding, process dynamics and output material quality as crucial continuous manufacturing elements that negatively impact material characterization. The FDA guidance lists a materials characterization facility as important to increasing production quality. Finally, realizing the predictability of material attribute variability on process performance and product quality is significant to the control strategy.

 

Solid Dosage Form

 

While analyzing the continuous manufacturing material flow process in a solid dosage form, the FDA guidance lists the following considerations that can impact powder feeding:

 

  • Particle size
  • Cohesiveness
  • Adhesiveness
  • Hygroscopicity
  • Static charge
  • Surface area of drug substances and excipients

 

Chemically Synthesized

 

While analyzing the material flow process in a chemically synthesized drug substance, the continuous manufacturing FDA guidance lists the following considerations that can impact flow properties:

 

  • Viscosity
  • Concentration
  • Multi-phase feed

 

Monoclonal Antibody

 

While analyzing the material flow process in a therapeutic protein (e.g. monoclonal antibody) substance, the FDA guidance lists the following continuous manufacturing considerations that can impact cell culture performance, process performance, or process consistency:

 

  • Lot-to-lot variability
  • Cell culture media
  • Different types of feed components

 

System Integration

 

The FDA guidance goes into depth about integrated systems characteristics and how equipment design can influence continuous manufacturing performance:

 

  • Design configuration
    • Maximum run time compatibility
    • Parts geometry impacting transformation
    • Integration and transfer steps
  • Design interface
    • Surge tanks
    • Mass flow rate
  • Material diversion and sampling
    • Diverter valve
    • Sampling probe
    • Material flow
    • Material transformation

 

The guidance continues to elaborate on equipment selection and how the equipment design, if executed properly, can help with process simplification.

 

Process Monitoring

 

Process monitoring and maintaining a state of control during production increases the understanding of real-time system performance. The FDA guidance states that these common approaches to process monitoring and control are also applicable to continuous manufacturing:

 

  • Established target setpoints
  • Established control limits
  • Design space
  • Measurement specifications

 

Process Analytical Technology

 

The FDA guidance also elaborates on why process analytical technology is suitable for continuous manufacturing. Examples provided by the agency for industry employees include:

 

  • In-line ultraviolet (UV) flow cells
  • Monitoring therapeutic protein concentration
  • In-line near-infrared spectroscopy
  • Assessing blend uniformity or water content
  • High-performance liquid chromatography
  • Monitoring the conversion of chemical reactions

 

About RCA’s Pharmaceutical Services

 

Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

 

  • Assessments
  • Audits
  • Continuous Manufacturing
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation 

 

Regulatory Compliance Associates has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

 

continuous manufacturingRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

continuous manufacturingSotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Sotera Health Announces Acquisition of Wisconsin-Based Regulatory Compliance Associates

Posted on by Brandon Miller

Acquisition strengthens Sotera Health’s quality, regulatory, and technical consulting capabilities

 

CLEVELAND, OH – November 9, 2021 – Sotera Health, a leading global provider of mission-critical sterilization and lab-testing and advisory services announced today that it has acquired Wisconsin-based Regulatory Compliance Associates (RCA). This acquisition expands the US-based quality, regulatory, and technical consulting capabilities of Sotera Health. RCA is an industry leader in providing life sciences consulting focused on quality, regulatory, and technical consulting for the pharmaceutical, medical device and combination device industries. Terms of the deal were not disclosed.

 

Headquartered in Pleasant Prairie, Wisconsin, RCA has extensive industry knowledge through a network of in-house and external experts and is known for its best-in-class solutions. Founded in 2000, the company has grown to be nationally recognized for its tailored, solution-driven approach to compliance related issues.

 

“Regulatory Compliance Associates is a premier provider of quality and regulatory services; known for its best-in-class solutions. It is also recognized for its strong relationships with its customers and regulators,” said Michael B. Petras Jr., Chairman and CEO of Sotera Health. “This acquisition will expand and further strengthen our technical consulting capabilities. We welcome RCA’s strong management and expert staff as they join us in our mission, Safeguarding Global Health®.”

 

“Our mission is to provide our customers with unsurpassed technical expertise combined with quality service. We have earned a reputation for our customer service and are seen as an essential partner for our customers—and we know we have found the same in Sotera Health,” said Erika Porcelli, CEO of RCA. “My goal for RCA is to continue our commitment to serve customers supporting their regulatory and compliance needs as they bring critical pharma and medical device products to market. We accomplish this by becoming part of Sotera Health, a global company whose breadth of services and expansive reach provide extraordinary value to the industries we are proud to serve.”

 

Regulatory Compliance Associates’ consulting capabilities will complement and enhance Sotera Health’s existing strengths in technical consulting and expert advisory services. Regulatory Compliance Associates is ISO 9001 accredited.

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.  Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.  

 

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.

 

About Regulatory Compliance Associates

Regulatory Compliance Associates® Inc. (RCA), is a life sciences consultancy focused on quality, regulatory, and technical consulting headquartered in Pleasant Prairie, Wisconsin with offices in Colorado and Florida.  RCA provides worldwide services for the resolution of compliance and regulatory challenges to the Pharmaceutical, Biologic & Biotechnology, Sterile Compounding, and Medical Device industries.  We understand the complexities of running a life sciences business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally regulated companies.  Achelous Partners provided investment banking and advisory services to RCA in the transaction. Learn more about Regulatory Compliance Associates at https://www.rcainc.com/.

 

Media Contacts:

Sotera Health:                                                                             

Kristin Gibbs                                                                                 

Chief Marketing Officer                                                            

kgibbs@soterahealth.com           

 

Regulatory Compliance Associates:

Erika Porcelli

Chief Executive Officer

E.Porcelli@rcainc.com

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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