Category: Uncategorized

EU Regulatory Update

Posted on by Joby Semmler

The European Commission’s formal pitch for revising the medicines legislative & EU regulatory framework was recently released. The new European regulatory documents targeting pharmaceutical industry reform & regulation law have been uploaded to the EU’s website. Multiple documents are included to help industry participants better understand the proposed regulatory compliance initiatives.

 

Regulatory Framework

 

The current European regulatory system is responsible for the evaluation & assessment of medicinal products. This regulatory process involves the European Medicines Agency (EMA), the competent authority of each EU member state, and subject matter experts on EMA scientific committees.

 

The proposed measures are designed to update the regulatory framework to accommodate the increase in EU pharmaceutical new product development. This includes requirements related to both clinical trials & real-world evidence. Additionally, secondary use of health data & regulatory sandboxes are also a focus of the legislation.

 

Regulatory Legislation

 

The new legislation draft mentions COVID-19 & the reduced availability of scientific resources has led to capacity constraints becoming more common. Further, this problem would continue without changes based on the current regulatory submission volume from drug companies.

 

Finally, the proposal mentions the current inefficiency of pharmaceutical product submissions. Regulatory submissions currently going through as many as five scientific committees to receive marketing authorization. A simplified regulatory framework is proposed to add flexibility so committee members have more time to concentrate on evolving pharmaceutical drug priorities.

 

Scientific Committees

 

The regulatory legislation draft proposes to reduce the number of scientific committees to just two:

 

  • Committee for Medicinal Products for Human Use (CHMP)
  • Pharmacovigilance Risk Assessment Committee (PRAC)

 

The CHMP & PRAC would continue to include pharmaceutical chemistry subject matter experts from each EU member state. The CHMP would also incorporate patient representatives on the new committee, a first of its kind for the European Commission. This representation of patients & health care professionals would consist of individuals with expertise in all areas, including rare & pediatric diseases.

 

Regulatory Training

 

New members of scientific committees from all EU member states would be offered different types of regulatory training opportunities. The goal for the EU regulatory training is to increase expertise in new areas of science & technology by partnering with top pharmaceutical companies & industry experts. This would help to relieve the current bandwidth issues many regulatory agencies & committees encounter, directly impacting new committee members who can contribute.

 

Further, training programs would be designed to help individuals assess & monitor pharmaceutical products. In fact, the proposal specifically mentions the speed of researching & approving cutting edge medicinal products from drug manufacturers.

 

Regulatory Procedure

 

The regulatory proposal continues by documenting the need for a reduction of regulatory burden on the committees. The opportunity to simplify regulatory procedures & increased digitalization are both mentioned as European Medicines Agency priorities. Additionally, this regulation meaning could influence electronic submission of applications & electronic product information (ePI) for approved pharmaceuticals.

 

Sunset Clause

 

Two measures designed to shrink the EU regulatory committee responsibility are the elimination of the renewal and the sunset clause. The EMA legal framework states the pharmaceutical research leading to marketing authorization of a medicine will:

 

  • Cease to be valid if the medicine is not on the market within three years of approval
  • Cease to be valid if the medicine is removed from the market for three consecutive years

 

While this does not represent a majority of pharmaceutical regulatory approvals, it does show the goal of the proposal is simplification. By reducing the regulatory burden of unnecessary policy, pharmaceutical companies should hopefully be able to expedite their dealings with the EMA. This will also amplify the streamlining of the new scientific committee structure. Finally, a more efficient regulatory process should help new pharmaceuticals move toward approval quicker and deliver product to patients sooner.

 

Paediatric Investigation Plans (PIPs)

 

Paediatric drug development is also evolving per the regulatory proposal draft. Clinical development plans for children at a young age currently requires pharmaceutical manufacturers to make statements about the anticipated results. As a result, regulatory teams submitting approval for novel therapies will be given more freedom to introduce a high level clinical development plan. Subsequently, this could help pharma manufacturing companies working on multiple novel treatments at the same time during the pharmaceutical product development process. 

 

Pharmaceutical Companies

 

So, who exactly does this proposed legislation help & would it impact pharmaceutical sales? According to the EMA, the reduction of administrative burden should benefit small & medium-sized EU pharmaceutical companies who have more challenges bringing new products to market. The regulatory legislation would also help not-for-profit bodies participating in pharmaceutical manufacturing research & development of new therapeutic products.

 

Industry Reaction

 

As anticipated, reaction from big pharma leaders has been swift & mixed. Martuscelli reports that policymakers want to tackle the uneven rollout of drugs across the EU. However, the proposed rules would remove two years of data protection from all new medicines launched in the European Union.

 

This would allow unbranded competitors to enter the market more quickly. Cutting drug market exclusivity for new medicines from ten to eight years will not go over well with pharmaceutical industry executives. Billions of dollars are spent annually on pharmaceutical technology & developing new products to address unmet needs of the patient. 

 

Stella Kyriakides, European Commissioner for Health and Food Safety, commented the proposal would help regulatory process by offering incentives for novel drugs & providing concrete action toward reducing drug shortages.  Additionally, transparent supply chains & leaner regulatory approval rules could increase the speed of pharmaceutical science programs. This is an important step as pharmaceutical supply chain members recover from the COVID-19 pandemic & drug shortages associated with the outbreak. 

 

About RCA’s 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, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows 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 pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • 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 pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

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

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

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

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

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

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

eu regulatoryRegulatory Compliance Associates® (RCA) provides pharmaceutical 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, Regulatory Compliance Associates 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 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

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.

 

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. 

Quality Assurance Services

Posted on by Joby Semmler

In the life science industry, 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 or drug is sent to market. At Regulatory Compliance Associates (RCA), we offer you the quality assurance services you need to monitor these quality processes and ensure quality compliance every step of the way.

 

RCA’s quality assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

Quality Consulting

 

The life science industry faces increased challenges as companies navigate the world of QA with fewer personnel. Strategic leadership is necessary for creating a quality management system, but this leadership requires a dedicated staff that many companies can’t afford. Outsourced quality support services are an ideal solution to this challenge.

 

Regulatory Compliance Associates can meet a variety of quality assurance services throughout your company’s product life cycle. Our quality consulting Experts provide trusted expertise while saving the money of hiring in-house staff. RCA can assist in situations such as:

 

  • Short-term augmentation due to transitions in staff:
    • Quality Assurance Consultant
    • Quality Control Consultant
    • Quality Engineering Consultant
    • Quality Management Consultant
    • Quality Systems Consultant
    • Software QA Consultant
    • Software Quality Assurance Consultant
  • Special projects
  • Strategic management and leadership of QA duties
  • New companies in need of QA insights
  • Root cause investigation
  • Corrective and preventive action support
  • Complaint handling
  • Recall management

 

Quality is something our software quality assurance consultants are experts at 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 quality engineering team.

 

QA Services

 

  • Quality Assurance Consultants – Interim Management, staff augmentation, or outsourcing quality and regulatory management has become increasingly common in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies.  Business consultant needs may vary greatly depending on the lifecycle of the organization, and RCA’s quality consultants are up to the task. 
  • QA Audit – Virtual gap assessments can assist your team in advance for an upcoming QA inspection by a notified body. These proactive organizations turn to RCA for management consulting Experts who can describe exactly what a notified body looks for.
  • Quality Assurance in Software Testing – Cybersecurity is becoming more essential to our industry based on updated FDA cybersecurity guidance. Pharmaceutical manufacturers partner with RCA for their cybersecurity FDA strategy and how to stay ahead of hackers. 

 

QA Process

 

Early in a company’s lifecycle, strategic leadership is needed for​ ​product filings, regulatory pathways, manufacturing setup, and quality management systems creation. As the company matures, QA planning often transitions to a continuous improvement stage when leveraging quality assurance services make sense.

 

  • Total Quality Assurance
    • Quality Assurance Methodologies
    • QA Procedures
    • Project QA
    • Product QA
    • Supplier QA
    • Digital QA
    • Agile QA

 

Outsourcing QA management can often provide a more strategic perspective when you’re challenged across changing quality control in engineering teams. The pharmaceutical quality experts of Regulatory Compliance Associates bring a wealth of quality assurance management needed to help you cut cost via unique QA methodologies.

 

QA Planning

 

  • Quality Control Audit
    • QA Procedures
    • QA Reporting
    • QA Responsibility
    • SOP Quality Control
  • QA Best Practices
    • QA Programmer
    • QA Project Manager
    • QA Software Tester
    • SQA Tester
    • Software QA Analyst
    • Software Quality Analyst
  • QA Testing Services
    • Standard Quality Control
    • Quality Control Tester
    • Quality Assurance Analyst
    • Data Quality Analyst

 

Software QA

 

  • Software QA Outsourcing
    • Agile Quality Management
    • Web Quality Assurance
  • Software Quality Control
    • Quality System Automation Using Software
    • Quality Systems Implementation
    • Quality System Remediation / Improvement
  • Quality Control Procedures
    • Computerized System Validation Standard Operating Procedure (SOP) – Our computer validation experts and software engineers have extensive experience with the GAMP5 validation model. RCA’s healthcare consulting Experts can ensure that you have the appropriate level of documentation.
    • Risk Management ICH Q9 – RCA’s business management consultant team can provide you with the tools needed to implement or remediate your quality systems. Every RCA® quality technical consultant understands current industry standards and how to train your personnel.

 

QA Teams

 

  • Corrective and Preventive Action (CAPA) and Complaint Systems – We manage the implementation and remediation of CAPA systems and Complaint Handling Systems.
  • 21 CFR Part 210 and 211
  • Quality Control Assurance
    • EU Good Manufacturing Practice (GMP)
    • Quality Assurance Best Practices
  • QA Testing Process
    • Performing Quality Control
    • QA Workflow
  • Quality Culture Guidelines
    • QA process
    • QA Tester
    • QA Analyst
    • QA Management
  • Laboratory Support
    • SOP Development
    • Method Transfer
    • Method Validation
    • Data QA

 

Medical Device Single Audit Program (MDSAP)

 

Regulatory Compliance Associates will help you navigate required activities as you prepare for an MDSAP audit. We offer MDSAP-based medical device quality consultant services to support you in the following areas:

 

  • Gap assessments to evaluate MDSAP requirement compliance
  • System improvements to assist with the transition to MDSAP
  • Preparation assistance and mock audits for the rigorous MDSAP audit process

 

ISO 13485

 

When you face restrictive deadlines to meet ISO 13485 requirements, Regulatory Compliance Associates quality assurance specialists are here. Our quality management system consultant team offers the following services, including:

 

  • Quality system transition and implementation
  • Quality system gap assessments
  • Readiness audits
  • Risk management (ISO 14971)
  • Data Integrity

 

About Regulatory Compliance Associates

 

Quality Assurance ServicesRegulatory Compliance Associates® (RCA) provides pharmaceutical 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 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

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.

 

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. 

How Brexit is Impacting Medical Device Companies

Posted on by Brandon Miller

Medical Device Regulations Changes coming with Brexit.

Listen to this highlight from RCA Radio where Seyed Khorashahi breaks down the UK’s Medical Device Regulations resulting from Brexit and choosing not to join the EU MDR.

 

 

Listen to the entire episode where we go over Brexit and all of the important things happening in the Medical Device industry here.

Looking for help adhering to the New Brexit Regulations? Contact Us Now →

Changes with Brexit

The UK will not be transitioning to the EU MDR or IVDR and will be staying with MDD, AIMD, and IVDD. They plan on making changes in the future as necessary for the UK market.

 

CE Marking

The MHRA will recognize the CE Mark for devices until June 30th, 2023. This applies to products CE marked under the

  • MDD, IVDD, AIMDD, and as well as MDR and IVDR.
  • Class I and General IVD manufacturers can continue to self declare.

 

Conformity Assessment Marking (UK CA)

  • UK Notified Bodies will become UK approved bodies starting January 1st, 2021
  • Device Manufactures can use UK approved bodies for UK CA marking starting on January 1st, 2021
  • UK CA marking will be mandatory on July 1st, 2023

 

MHRA Registration Requirement Dates

 

  • May 1st, 2021
    • Class III medical devices & IVD list A devices
    • Class II b implantable devices
  • September 1st, 2021
    • Class II b non-implantable and II a & IVD list b products
  • September 1st, 2022
    • Class I medical devices and general IVDs

 

UK Responsible Person

Manufactures without a presence in the UK will need a UK responsible person which can be an individual or company similar to EU authorized representative.

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information 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 can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance 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 international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance 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. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

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 regulatory compliance 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
  • Combination Products

 

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
  • Data Integrity

 

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 quality assurance services 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
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & 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.

 

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

 

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
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

medical device consultingRegulatory 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, Regulatory Compliance Associates 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 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.

 

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.

 

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. 

 

Pharmaceutical Supply Chain Consulting

Posted on by Joby Semmler

About Regulatory Compliance Associaties

 

Regulatory Compliance Associates (RCA® ) provides pharmaceutical supply chain 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, supply chain, 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 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.

 

RCA Pharmaceutical Supply Chain Consulting Services

 

The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:

 

Assessments 

 

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

 

Our range of compliance consulting services includes:

 

  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.

 

Audits 

 

Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:

 

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

 

Regulatory Agency Response 

 

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

 

  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans

 

Preparation, Training, and Inspection Readiness 

 

Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:

 

  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations

 

Data Integrity

 

Training:

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting:

 

  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

cGMP Consulting

 

Maintaining data integrity is an important part of ensuring the manufacturing quality of your pharmaceutical. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

 

In a time when compromised data has become a common concern among businesses in the life science field, it’s become more critical than ever to maintain healthy practices concerning data storage and release. Medical device companies of all sizes and types need to trust their data’s integrity, which is why thousands of businesses have turned to Regulatory Compliance Associates® for GMP quality compliance services.

 

With a team of more than 500 industry experts and seasoned veterans of the FDA, we know what it takes to adhere to the standards of global regulatory bodies. We offer the expertise needed to help your business stay within cGMP and preserve your data’s integrity. Our array of training and consulting services will ensure that your customers’ trust in your brand is well-placed.

 

GMP Quality Compliance Services

 

Training

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting

 

  • cGMP Consulting
  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with the execution of Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of your medical device—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

Manufacturing Processes

 

Our comprehensive evaluations will identify GMP pharmaceutical practices that consistently yield a sustainable return on investment. We will help you identify opportunities for:

 

  • Reducing Set-Up Times
  • Increasing Throughput
  • Reducing Inventory Levels
  • Lab Efficiency Improvements
  • Scrap and Waste Reduction
  • Cycle Time Compression
  • Capacity Creation
  • Process Automation
  • Cost Reduction

 

Manufacturing Optimization

 

Regulatory Compliance Associates provides the following manufacturing optimization services:

 

  • Program Analysis
  • Process Optimization through Engineering Studies
  • Statistical Process Control
  • Lean Innovative Product / Process Solutions
  • Value Stream Mapping
  • Kaizen Events
  • Design for Six Sigma
  • Inventive Problem Solving

 

Automated Industrial Services

 

Regulatory Compliance Associates  provides manufacturing automation consultants with deep industry experience including:

 

  • Validation Master Plan
  • Development of Validation Documentation
  • Validation Services
  • Risk Assessments

 

Factory Automation

 

Regulatory Compliance Associates helps clients develop innovative factory automation via design strategy and hands-on validation support. We ensure that updating manufacturing facilities will continue to meet all regulatory and client requirements, without an adverse impact on the finished product.

 

  • HVAC Systems and Associated Controllers
  • Medical Gas Systems
  • Plant and Pure Steam Systems
  • Water Systems including USP, RO / DI, and WFI
  • Compressed Air Systems
  • Controlled Environments

 

Pharmaceutical Contract Manufacturing

 

When you choose Regulatory Compliance Associates as your pharmaceutical manufacturing consultant, you’ll have the support of validating every contract manufacturer. RCA provides the combined skills and knowledge of more than 500 pharmaceutical and medical device experts who are experienced at working on the front lines of regulatory requirements. RCA clients benefit as these solutions move suppliers toward a culture of quality, from startups to Fortune 100 international enterprises.

 

Quality Management System

 

To create a positive change in the lives of patients counting on the availability of your product, you need to recognize the regulatory pathways of drug manufacturing companies that are ahead of you. Further, this includes the evolving technical development of your quality management system. When you work with us, you get a team that tailors its services to the comprehensive needs of your company. And that’s how you can be assured you’ll always receive the support you need to implement corrective action wherever it may be needed.

 

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. 

 

 

Pharmaceutical Consultants

Posted on by Joby Semmler

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting & 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 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.

 

About RCA’s 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 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 pharmaceutical consultants 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® Inc.’s 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
  • Combination Products

 

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 Regulatory Compliance Associates, our pharmaceutical consultants offer the experience and resources necessary to guide you in quality compliance.

 

  • Assessments
  • Compliance Audit
  • Internal Audit
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity 

 

Quality Assurance

 

Regulatory Compliance Associates® Inc.’s 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
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates® has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that the regulatory agency will accept 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
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

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 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
  • Risk Management Plan

 

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 Services

Posted on by Joby Semmler

About Regulatory Compliance Associates

 

regulatory compliance servicesRegulatory Compliance Associates (RCA) provides regulatory compliance services & consulting services to the following industries for resolution of complex life science industry 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 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 5,000+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

About RCA’s Pharmaceutical Regulatory Compliance 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® will guide you through every step of the regulatory process. Our regulatory compliance services team 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®’s 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 regulatory compliance services Experts. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

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
  • Audit
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

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 regulatory compliance services consultants include experiences that span both major corporations and seemed start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this consulting services knowledge to your organization.

 

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

 

Remediation Services 

 

Regulatory Compliance Associates® has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other regulatory enforcement 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 corrective action and preventative action (CAPA) strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About RCA’s Medical Device Regulatory Compliance Services

 

The 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. RCA®‘s regulatory compliance 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 regulatory compliance services 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 product development, 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.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

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 that 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® Inc. can help.

 

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

 

  • Gap Assessments
  • Internal Audit
  • Compliance Audit
  • Medical Device Audit
  • 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 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 every standard operating process from day one of the design of a new product. Additionally, the regulatory compliance process continues as the device is sent to market — and now postmarket. At RCA®, we offer you the assistance you need to monitor these processes and ensure quality compliance every step.

 

With more than 20 years of experience as a trusted GMP & cGMP 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 GMP response by helping companies successfully execute their action plans. Each regulatory compliance services SME will help you develop an improved compliance culture tailored to the needs of your business. Additionally, many RCA clients ultimately beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our compliance consulting experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

 

  • Regulatory Compliance
  • Regulatory Enforcement
  • 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 products so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500+ regulatory compliance services 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. 

 

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