Regulatory Compliance Associates® Inc.’s background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs.

With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical expertise to 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

Regulatory Affairs

Compliance Assurance

Quality Assurance

Remediation Strategy and Support

Strategic Consulting

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 pharmaceutical 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
As the backbone of RCA, our regulatory affairs services are equipt to handle unique regulation challenges in the pharmaceutical industry, from New Product Support to Life Cycle Management. We manage regulatory needs throughout the pharmaceutical industry.
Whether you need a regulatory strategy to get a drug approved, an implementation plan for a new project or a corporate needs analysis, RCA's team of seasoned experts provide the insight you need to help you comply with standards, reduce costs, assess personnel and complete other vital tasks associated with strategic planning.
RCA's quality assurance services for pharmaceutical companies include assessment, analysis, implementation and identification of quality metrics for continual company improvement. Our expert team has firsthand knowledge of the steps needed to improve the quality of your organization and will provide you with the services necessary for your pharmaceutical business to implement and maintain this knowledge.
With increasing industry compliance demands, life science companies are feeling growing pressure from regulators. RCA's compliance assurance experts help you thoroughly prepare for audits, respond to regulatory agency findings and remedy an unfavorable event through services such as mock inspections, FDA inspection training and implementing a response plan.
At RCA, we understand how significant an impact a compliance crisis can have on your business. We partner with your executive and legal teams to provide the ideal remediation strategy for your situation and assure the best possible outcome.

News

Vice News Interview: Coronavirus Is Revealing Gaping Holes in America’s Drug Supply Chain...
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News

Vice News Interview: Coronavirus Is Revealing Gaping Holes in America’s Drug Supply Chain...
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News

Vice News Interview: Coronavirus Is Revealing Gaping Holes in America’s Drug Supply Chain...
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Regulatory Compliance Associates® Inc. Welcomes Steven Lynn as Executive Vice President of Pharmaceuticals...
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Regulatory Pathways for Medical Device and Pharmaceutical Filings and cGMP Compliance Considerations...
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