Pharmaceutical

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