Regulatory Affairs

Medpace global regulatory experts have experience in all aspects of the clinical trial submission process, to both IRBs/ethics committees and to FDA and global regulatory authorities. Up-to-date in the evolving regulatory requirements by region, every Medpace project team is fully-engaged from program initiation to reporting of results across Phases I-IV of drug development. Our cross-functional teams are well-coordinated to execute a collaborative approach to optimize every regulatory component of your clinical trial.

Medpace has strategic regional regulatory presence throughout Europe, Asia, Australia, South Africa, and the Americas. Medpace has developed and maintains Electronic Common Technical Document (eCTD) capabilities for full NDA filings, which have been validated by the FDA in both mock and actual application submissions. Our dedicated experts are focused on producing the most meaningful, comprehensive, and submission-ready compilation of your non-clinical and clinical data and manufacturing information – ensuring compliance with global regulatory agency requirements and guaranteeing every phase of the trial is correctly focused for optimum results.