Regulatory Affairs and Quality Assurance Services

Quality Assurance (QA) and Regulatory Affairs (RA) are two complementary processes that are essential for ensuring the safety of participants, the integrity of data, and compliance with legal and ethical standards. 

Versiti Clinical Trial Services offers sponsors the experience and streamlined workflow to smoothly navigate complex regulations and ensure compliance. Our team is well-versed in advising on regulatory strategies, optimizing global filings, and enhancing submission quality through expert scientific writing.

Versiti Clinical Trial Services supports organizations across the biopharma, medical device, and diagnostics landscape—from emerging startups to global manufacturers. Our seasoned consultants provide risk-based regulatory and quality assurance guidance to help teams navigate complex domestic and international regulations, strengthen compliance throughout the product lifecycle, and reduce operational and regulatory risks.