Regulatory Affairs
Drug Master File (DMF)
Chief Pharmacist
A DMF is a confidential document submitted to the FDA by a pharmaceutical manufacturer, containing detailed information about the facilities, ...
Regulatory Authorities
Chief Pharmacist
Regulatory authorities enforce legal frameworks for new drug products or medical devices approval in market. For example, US FDA oversees ...
Dossier
Chief Pharmacist
It is a set of documents which contains technical information about the drug product. The information includes administrative, quality, non-clinical ...