Regulatory Compliance Associates® will be at MD&M East in New York City June 13th – 15th. Join us in the Sotera Health booth #1433 with Nelson Labs and Sterigenics to get answers for any of your medical device quality, regulatory, compliance, lab testing, and sterilization needs.

We will also be offering free presentations in the Tech Theater and a half day seminar, on the show floor.

Tech Theater:

Date: Tuesday, June 13, 2023
Time: 1:30-2:15 PM
Location: Tech Theater
Title: Big Changes to ISO 10993-1, What is Happening to the Main Biocompatibility Standard Now?

In 2018, TC194, the ISO committee for biocompatibility, released a new version of 10993-1. This new version focused more on a risk-based approach and made significant changes. Then in 2021, a radical proposal to update the standard again was issued with a new draft of the standard. We are now more than a year into writing and compromising the draft of this crucial standard. In this talk we will go into the latest on the standard that is being changed, the reasoning behind those changes, and possible future acceptance of the standard around the globe.

Presenter: Thor Rollins
Vice President, Global Market Segment Leader—Medical Device

Date: Wednesday, June 14, 2023
Time: 1:30-2:15 PM
Location: Tech Theater
Title: Cobalt-60: Investing for the Future of Gamma Sterilization

Gamma sterilization has been the predominant radiation sterilization modality for decades and accounts for more than 30% of all single-use medical device sterilization globally. Gamma sterilization relies on the ongoing supply of Cobalt-60 to the global market. In this session, you will learn how Cobalt-60 is produced, and get updated information on efforts underway in the global supply chain to not only expand production to meet growing demand but also improve utilization of this critical resource. The presentation will also include a discussion on the sustainability of Cobalt-60 and gamma sterilization.

Presenter: Richard Wiens,
Director, Business Development & Strategic Supply, Nordion

Free Seminar: 

Date: Wednesday, June 14, 2023
Time: 10:30 am to 1:30 pm
Location: MDM Show floor- 3D06
Title: Updates & Trends: Learn about the Most Recent Biocompatibility and Reprocessing Updates to Standards

10:30 am to 12:30 pm
Title: Updates on Biocompatibility Standard Changes, What is Happening With 10993-1, 5, 10, 12, 17, 18, and 23.

Over the past decade, biocompatibility standards have been constantly evolving. In recent years, we have witnessed the introduction of a new standard (10993-23), significant updates to existing ones (10993-12 and 10993-18), as well as the development of new drafts (10993-17) and active working groups that are working on making further changes (10993-1 and -5). During this talk, we will review these standards and discuss the modifications that have already been implemented, as well as those that are currently being proposed. Attendees will gain comprehensive knowledge of the latest biocompatibility standards and understand how they should be applied when submitting regulatory documents.

Presenter: Thor Rollins
Vice President, Global Market Segment Leader—Medical Device

12:30 pm to 1:30 pm
Title: Updates on Reprocessing Validations for Reusable Medical Devices

As reusable medical devices continue to advance, the validations used to evaluate the reprocessing (cleaning, disinfection, and/or sterilization) procedures have had to advance as well. These advancements have resulted in numerous standards and guidance documents being either updated or created to ensure that reusable medical devices can be safely reprocessed. This presentation will discuss these changes as found in documents such as AAMI ST98, AAMI TIR12, ISO 17664, as well as others. Additionally, this presentation will discuss how these changes impact new and already completed reprocessing validations for reusable medical devices.

Presenter: Griffin Cammack
Expert Technical Consultant

About RCA® Medical Device Services

mdm westThe 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 industry 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.

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® 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 veterans and industry 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® can help.

Our network of over 500 FDA 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® 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 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 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans 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 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® 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® worldwide experience 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 and FDA 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 RCA®

Regulatory Compliance Associates® (RCA) provides healthcare 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.

 

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. 

 

PLEASANT PRAIRIE, Wis.Nov. 25, 2019 – Regulatory Compliance Associates® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces Erika Porcelli has accepted the position of Chief Executive Officer.

 

“Bringing more than 20 years’ experience in relationship building, Erika’s focus for 2020 is centered on the customer experience,” said Board Chairman, Mitch Januszewski. “Erika brings a wealth of experience and energy to the company. We are looking forward to Erika’s client-focused leadership and the roll-out of client-centric initiatives in the new year.”

 

“More than ever before, we will be focusing on building relationships and putting our clients first,” said Porcelli. “We will be introducing new tools and processes to both streamline and deepen our client communications and ensure we’re consistently delivering the greatest value.” Having touched all aspects of RCA services, it’s these relationship-driven interactions that Porcelli values most.

 

Prior to her role as CEO, Erika Porcelli served as Senior Director of Business Development for RCA’s northern U.S. territory and, most recently, Vice President of Client Relations. She brings her extensive knowledge in marketing programs, analysis and market research, marketing communications, and sales process opportunities, as well as in-depth knowledge of the pharmaceutical, biotech, and medical device industries.

 

Additionally, she has expertise in new business development, contract negotiation, and budget management. Erika Porcelli is also the host of RCA’s podcast, RCA Radio, which launched in June 2019.

 

Erika Porcelli

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides life science 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-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)
    • Regional offices in Florida, Colorado and Europe
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

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. 

Regulatory Compliance Associates® will be exhibiting at INTERPHEX in New York City from April 25th–27th 2023 with Sterigenics and Nelson Labs. Stop by booth #1753 to meet experts from each team 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.

interphex

Regulatory Compliance Associates® Distinguished Fellow and the Parenteral Drug Association® (PDA) Chair of Board of Directors, Susan Schniepp, will be presenting a tech talk where you will learn more about contamination control strategy, how to identify and assess risk, prepare mitigation pathways, and define preventive actions associated with contamination in sterile product manufacturing.

Sue is the knowledge leader for RCA® and is Chair of the Parenteral Drug Association (PDA) Board of Directors. Sue’s background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.


About Interphex® 2023

For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.

interphexBased in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.

 

About Regulatory Compliance Associates’ 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® 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®

pharmaceutical consultantsRegulatory 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. 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.

 

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. 

Join Regulatory Compliance Associates (RCA) at the Anaheim Convention Center in Anaheim, California February 7th through 9th for MD&M West this year. Meet us in Nelson Labs booth #3135 to connect with RCA’s Director of Regulatory Affairs, Jordan Elder.

During the conference, Jordan will also be presenting “Ask the Expert: Regulatory Hot Topics” during the full-day seminar on Wednesday, February 8th: Medical Device Validation – Biocompatibility, Cleaning, Sterilization, and Packaging Testing in room 207CD. (We encourage you to register now for the full day seminar; however, we will allow on-site registration.)

Jordan Elder has almost 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for both pharmaceutical and medical device companies.

 

Presentation: Ask the Expert: Regulatory Hot Topics

Abstract: Our regulatory expert weighs in on industry hot topics such as EO sterilization, Biocompatibility, EU MDR, and Clinical Evaluations, as well as questions asked by conference attendees. The discussion will include current trends and common regulatory pitfalls and aims to provide answers to unanswered attendee questions. If you are interested in having a question included for review and discussion, please reach out to J.elder@rcainc.com.

 

 

About Informa Markets Engineering and MD&M West

Informa Markets Engineering West (IME West), home to MD&M West, WestPack, ATX West, D&M West and Plastec West, is the largest annual advanced manufacturing event in the US, bringing together suppliers and buyers for every part of the product development cycle.

MD&M West encourages innovation that results in solutions – both simple and complex – by building a community of experts, engineers, and thought leaders and bringing them together every year to engineer life-saving devices.

Much more than a medical technology trade show, MD&M West exists to improve lives through continuing education, sharing knowledge, and bringing opportunities to all.

 

About RCA® Medical Device Services

mdm westThe 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 industry 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.

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® 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 veterans and industry 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® can help.

Our network of over 500 FDA 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® 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 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 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans 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 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® 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® worldwide experience 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 and FDA 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 RCA®

Regulatory Compliance Associates® (RCA) provides healthcare 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.

 

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. 

 

regulatory compliance

Regulatory Compliance Associates® will be exhibiting at CPhI North America 2023 in Philadelphia with Sterigenics and Nelson Labs. Stop by booths #934 and #932 to meet experts from each team 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 CPhI NA

CPhI organizes the most important and widespread series of global pharmaceutical events. Our gatherings are both renowned and revered—but it didn’t start in North America. With massive events throughout Asia, South America, Europe, and beyond…more than 500,000 powerful and respected pharma players from every aspect of the supply chain understand that CPhI is where they connect to learn, grow, and conduct business. With a 30-year tradition and an infrastructure fine-tuned to unite buyers, sellers, and industry trailblazers, we expanded this iconic worldwide events portfolio into the most progressive mega market on earth.

 

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® 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.

 

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. 

 

 

Regulatory Compliance Associates® Inc. is pleased to announce that our distinguished fellow, Susan Schniepp, has been elected as the Parental Drug Association (PDA) Board of Directors Chair for 2022-2023.

 

The PDA is a recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology.

 

Parental Drug Association

As Chair, Susan will help ensure that the board of directors is effective in its task of setting and implementing the Parental Drug Association direction and strategy and she will provide leadership to the other officers and executives. She was voted in and will begin her duties as the Chair at the start of 2022.

 

We are looking forward to seeing how her influence at the Parental Drug Association will help advance the industry in 2022.

 

About RCA

Regulatory 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-and globally-regulated companies.

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

 

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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