Expert knowledge and experience matters. Pharmatech’s team of seasoned industry experts have a deep understanding of the rigorous regulatory application and submission process. From formal agency meetings and pre-submission packages through full electronic filing of your product application, we have the insight to help accelerate your program using proven strategies and techniques. The regulatory approval process requires a diligent scientific and statistical foundation upon which carefully structured and articulately drafted documents are used to make the case for your product’s rapid and successful approval.
CHEMISTRY/ MANUFACTURING/ CONTROLS (CMC)
PRE-APPROVAL INSPECTION PREPARATION AND READINESS
REGISTRATION STRATEGY, REPORT WRITING AND FILING SUPPORT