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Regulatory Affairs

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.