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 expertise on worldwide registration of prefillable delivery systems.
The BD Regulatory Affairs team provides customers with the regulatory information and/or access to it, depending on the targeted region(s) for registration : • For applications in USA (CDER, CBER, CDRH, CVM), Canada and Australia, BDM-PS Regulatory Affairs team provides a Letter Of Authorization(LOA) which allows the appropriate health authority to review a BDM-PS Master File against a customer's drug application. • For applications in other countries, the BDM-PS Regulatory Affairs team provides a Technical Dossier(TD) of BD container closure system under a signed Confidentiality Disclosure Agreement(CDA) for regulatory purposes.
The Technical Dossier contains general information on BD products that may be included in customer's applications.
The request for LOA or TD should be handled by a Regulatory Affairs Representative.
