Services: Audits-Device

For Medical Device Industry

Medical Device Single Audit Program (MDSAP)

MDSAP is a standardized global auditing program which allows for a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to be conducted to satisfy the requirements of several global regulatory agencies and/or regulatory bodies. 

MDSAP was conceived in 2012 (launched in 2014) by the International Medical Device Regulators Forum (IMDRF).  The program officially completed the pilot phase in December of 2016 and manufacturers are now able to begin the process for certification.  Currently 5 countries are participating in the program and they include: USA, Canada, Australia, Brazil and Japan.  The World Health Organization (WHO) and the European Union (EU) are Official Observers.  One special area of consideration is that manufacturers selling products in Canada have a deadline of January 1, 2019 to become certified in order to continue to sell their products on the Canadian Market. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) in Canada. The two (2) year transition period in Canada started on January 1, 2017 and continues through January 1, 2019. At the end of this transition period, only MDSAP certificates will be accepted. 

 

Global Regulatory Authorities Designated Use of the MDSAP Audit Reports
US – FDA The FDA will accept the MDSAP Audit Report in lieu of FDA routine inspections.However, MDSAP does NOT apply for certain types of regulatory inspections including:·         “for cause” inspections·         “compliance follow-up” inspections; or·         pre-or post-approval inspections for PMA (Premarket Authorization)
Canada – HC MDSAP will replace the Canadian Medical Device Conformity Assessment System (CMDCAS) by the end of the (2) two year transition period in Canada [January 1, 2017 to January 1, 2019]. After the transition period ends in Canada, only  MDSAP certificates will be accepted.
Australia – TGA MDSAP Audit Reports may be used to support compliance with the medical device authorization requirements (unless the particular medical device is excluded or exempt from the requirements)
Brazil – ANVISA MDSAP Audit Reports may be used to support the technical evaluation of the premarket and post-marketing requirements.
Japan – MHLW and PMDA MDSAP Audit Reports may be used to support the premarket and postmarket requirements.

 

MDSAP audits must be conducted by recognized Auditing Organizations (AO) authorized by the participating global regulatory agencies and/or regulatory bodies pursuant to the MDSAP requirements.  These will be conducted on an annual basis based on a (3) three year certification cycle.

 

What to expect in the MDSAP audit:

During your MDSAP audit, you should expect the Auditing Organization to cover all elements of ISO 13485 (Management, Device Marketing Authorization, Measurement and Analysis, Medical Device Adverse Events Reporting, Design and Development, Production and Service Controls, and Purchasing) with a heavy emphasis on:

  • Incorporation of risk within all processes to manage your product lifecycle
  • More scrutiny on your outsourcing practices
  • Both design and process validation
  • Design change management and risks associated with these changes

 

Value Proposition

Traditionally, manufacturers selling their products globally were faced with the challenge of being audited by multiple regulatory authorities causing disruption to manufacturers.  MDSAP evolved because it was recognized that a single audit would be more efficient while ensuring the Quality Management System was thoroughly covered during an audit.  It also provides consistency in the audit process and minimizes the burden on resources.  All important factors when you consider efficiency goals within an organization.

 

What’s in it for the Regulatory Authorities?

  • Creates a coalition of countries utilizing shared technology, resources, and services to improve the oversight of medical devices more efficiently.
  • Better utilizes the widely accepted international standards and best practices to achieve alignment of regulatory approaches of multiple regulatory bodies.

 

What’s in it for the manufacturer?

  • One audit overall instead of one per Regulatory Authority means less burden on manufacturer resources to deal with multiple audits.
  • Use of standardized non-conformity grading system will make the outcomes more predictable.
  • Utilization of a consistent audit criteria compliant to the requirements of all participating regulatory authorities will be used by the Auditing Organizations.
  • Saves you time and money by participating in 1 audit versus multiple audits.

 

Country specific Adverse Event Reporting

  • In 2012 Australia made access available to the Database of Adverse Event Notifications (DAEN). The database is searchable by report number, date, manufacture, sponsor, etc. 
  • The Manufacturer and User Facility Device Experience (MAUDE) has been available since 1996 and is also searchable by report number, date, manufacturer, etc. The product problems are categorized into more than 1,000 device and patient problems as defined by Code 3500A
  • Canada utilizes what is referred to as the Adverse Reaction Database. The search criteria is more limited however, reports date back to 1965.
  • Japan and Brazil also have information available publicly however, the incidents are only available in the local languages.
  • European Database on Medical Devices (EUDAMED)*
    • EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.
    • EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.
    • EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.

*Note, EUDAMED is expected to be operational in March of 2019.  Note this date is subject to change.

 

About RCA’s Medical Device Consulting Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post-market compliance throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. 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 Inc.®, 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 products 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 medical device consulting to the following industries for the resolution of life science challenges:

 

 

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

 

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

 

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

 

About Sotera Health®

 

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

 

Sotera 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. 

 

Compliance Assurance

Medical Device Compliance Consultant Services

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and need healthcare compliance consulting.  Whether it’s preparing for a compliance audit or developing a response to an FDA 483, or remediation to an adverse event,  Regulatory Compliance Associates (RCA) can provide regulatory compliance consulting support to ensure your company’s needs. We respond quickly and thoroughly by developing a unique sustainable compliance strategy based on each individual market.

 

Set up your Scoping call today. Contact Us Now

 

 We provide a range of medical device Compliance Assurance Services, including:

 

 

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. You may also email us at [email protected].

Audits

Compliance Audit Consulting

 

Today’s medical device companies face more pressure than ever to meet the increasing and evolving demands of an internal audit. Many businesses are implementing a risk assessment internal audit to identify insufficiencies, evaluate risks, and determine inspection readiness. These strategies smooth the regulatory compliance audit process and provide a greater chance of FDA audit success.

 

Conducting periodic internal audits is one way that many companies choose to ensure compliance with ISO standards, cGMPs and international regulations. At Regulatory Compliance Associates®, we have healthcare compliance audit expertise with both short, targeted internal audits and more substantial assessments across the quality management system. No matter what your goals are, RCA’s regulatory audits team will teach you how to prepare for an FDA audit & increase FDA inspection preparedness.

 

Internal Audit Services

 

Using an RCA audit risk-based strategy, Regulatory Compliance Associates® will help your company identify and correct compliance deficiencies and choose the best regulatory compliance audits for FDA inspection readiness.

 

ASQ-CQA or Exemplar Global certified auditors are available for the following medical device audits:

 

  • Current Good Manufacturing Practices (cGMP) Compliance Audits:
    • Manufacturing, Pilot Plant, Laboratory Facilities
    • CAPA Audit
      • FDA Audit Preparation
      • FDA Audit Training
      • FDA Audit Support
  • Current Good Laboratory Practices (cGLP) / cGMP Compliance Audits
  • Regulatory Gap Analyses
    • Pre-Approval Audits
    • CFR Part 11 Gap Analysis
    • Risk Assessments
    • FDA Audit 483 Observations
  • Quality Systems
    • 21 CFR 820 Audit
    • ISO 13485 Audit
    • Development of Inspection Checklists
  • Internal Audits
    • Contract Manufacturer Audits
    • Supplier Audits
    • Scribe Audit
    • Virtual audit
  • Medical Device Single Audit Program (MDSAP)
    • MDSAP Compliance Audit Readiness

 

The RCA Advantage

 

Compliance gaps can sometimes blindside even the most prepared medical device companies during agency inspections. Teaming with Regulatory Compliance Associates® ensures you’ll be as prepared as possible to face FDA audit questions.

 

As an industry-leading risk assessment consultant, we offer a host of compliance audit services:

 

  • Our staff are seasoned audit experts — many have decades of experience working with the FDA and preparing for FDA inspections.
  • We understand audit preparedness — RCA’s compliance consulting team has in-depth knowledge of FDA regulations for medical devices so that you know exactly how to plan for your FDA inspection.
  • We not only offer healthcare audit services, but we also have the processes in place to help you make sense of findings and manage the corrective action process.
  • Not only does our audit scribe team monitor problems that regulatory agencies are likely to uncover, but we also consider the big picture to ensure the compliance of your quality management system.

 

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 medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consultant Experts — including former FDA officials and 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 medical device consulting companies 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.

 

Regulatory Affairs

 

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

 

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

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • 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 consultants & 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.

 

  • Data Integrity
  • Compliance Audit
  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

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

 

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

 

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

 

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

 

Remediation Services

 

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

 

Our compliance audit 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 
  • Quality Metrics

 

Strategic Consulting

 

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

 

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

 

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

 

About Regulatory Compliance Associates

 

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

 

 

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

 

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

 

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

 

About Sotera Health

 

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

 

Sotera 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.

 

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. 

 

Manufacturing Automation for Medical Devices

Background

A medical device client designed and built manufacturing automation to assemble and weld medical-grade check valves.

The automation component of the equipment consisted of a PLC, an HMI, a vision system, and an ultrasonic welder. An ISO audit found that the software driving the client’s automated assembly equipment had not been validated. Additionally, new, urgently needed equipment had recently been built and needed validation, but the client did not have sufficient software validation expertise available in-house.

Approach

RCA provided software validation as an integral part of equipment validation. A risk assessment was performed to determine which user and functional requirements represented the greatest risk to product quality and patient safety (per GAMP 5). The manufacturing automation functions that presented the greatest risk received the highest level of testing to ensure that the automation equipment consistently assembled components to meet critical product specification requirements. This approach provided a robust validation and reduced the overall validation project timeline.

Challenge

Regulatory Compliance Associates® Inc. (RCA) was contracted to develop validation documentation and provide validation services to ensure software was adequately validated and the valve assembly machine was prepared for production. The entire process required completion within an aggressive time frame.

Result

The validation was completed within the aggressive time frame, and the validation effort focused on equipment functionality that represented the highest risk to product quality and patient safety. The client received a defendable validation and the new equipment was available for production by the project target date.

 

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. 

 

Supply Chain Audit

With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains intact. In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, discuss the problems these companies are facing.

Listen in as we go over supply chain audit effectiveness and oversight of service providers. We break down the different ways companies can work virtually to get audits done successfully. The challenges with recording audit findings and conducting interviews. What companies can do to audit suppliers and maintaining their supply chains. As well as answer the questions; is virtual auditing going to be a long term solution, and what companies can do to maintain oversight of service providers.

 

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 and create a customized approach depending on your product and your pharma 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, 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 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, and we excel in transferring pharma consulting 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

 

pharmaceutical consultantsRegulatory 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.