Why Early Site Inspections, Vendor Audits, & QMS Development Matter More Than Ever in Drug Development

In today’s rapidly evolving biopharma landscape, regulatory scrutiny, supply-chain complexity, and quality expectations continue to intensify across both the United States and Europe. As FDA resumes and expands inspection activity post-pandemic, and European regulators reinforce harmonized GMP oversight through EMA and national authorities, including the UK MHRA, proactive quality and compliance strategies have shifted from “nice to have” to strategic necessities for any drug developer.

Organizations are no longer preparing for each individual regulator. They’re preparing for converging expectations across FDA, EMA, and UK frameworks, where inspection readiness, data integrity, and supplier oversight must withstand scrutiny on both sides of the Atlantic.