DRUG MASTER FILES (DMF)
Drug Master Files (DMF)
An appropriate Chemistry, Manufacturing and Control (CMC) regulatory document such as a Drug Master File (DMF) or Active Substance Master File (ASMF) that is available by Bachem contains the relevant details of the manufacturing process for an Active Pharmaceutical Ingredient (API) enabling competent authorities (e.g. FDA, EMA) to review process information in support of third party drug product marketing applications. Bachem will provide a letter of authorization/access that will allow the relevant authorities to review the DMF. In addition to submitting regulatory documents in the United States and Europe, Bachem has broad experience filing regulatory documents throughout the world.