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The BD Medical-Pharmaceutical Systems (BDM-PS) Regulatory Affairs team supports customers with their applications to optimize time-to-market and to help manage the regulatory life-cycle of BD products. The Regulatory Affairs team offers regulatory support on registration of BD products.
The team is composed of Regulatory Affairs Professionals, experienced in Pharmaceuticals and Medical Devices, and located in U.S.A., EU, in direct contact with BD Regulatory Affairs associated located in many countries (Australia, Brazil, Canada, China, India, Japan, South Korea, Mexico, Russia, ...).
The BD Regulatory Affairs team provides:
• Letter Of Authorization (LOA) for applications in USA, Canada and China, which allows the appropriate health authority to review a BDM-PS Master File against a customer's drug application. Request form for LOA
• Technical Dossier (TD) for applications in other countries. TD contains general information on BD products that may be included in customer's applications.Request form for TD
• Support to any regulatory inquiry. Other Regulatory Request form
