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 filed
by Pharmaaffiliates 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. Pharmaffiliates 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, Pharmaffiliates has broad
experience in filling regulatory documents throughout the world.
Abbreviated New Drug Application (ANDA)
Pharmaffiliates strategic approach to successful ANDA submission focuses on gathering
the appropriate ANDA information to ensure a complete application while conducting
the right clinical studies. We rely on decades of experience to power bioequivalence
(BE) studies and minimize study failures. This competency in clinical study design
is invaluable for ANDAs that require clinical endpoint studies.