BIO
The Drug Master File (DMF) accelerates the regulatory process by simplifying the communication between the Sponsor of the drug, the vendor used to fully manufacture the drug or a component of the drug, and the health authority.
In the Advanced Therapeutics (ATMP) industry, Contract Development and Manufacturing Organizations (CDMOs) are commonly used by many Sponsors to manufacture advanced therapy drug candidates due to manufacturing complexity and lack of existing manufacturing infrastructure.
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