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Case Study 3

US FDA New Drug Application (NDA) Submission

A US-based life sciences company approached Trinity M Consulting for support with medical writing and project management for an upcoming US FDA New Drug Application (NDA). Trinity M Consulting, Medical Writer was assigned to project, leading the team in the preparation of clinical and non-clinical modules following Electronic Common Technical Document (eCTD) format. Trinity M Consulting, offered crucial guidance to extended team with the filling, compiling, and in the authoring of clinical pharmacology studies. Project was completed successfully within timelines without major risks.

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