Drug Master File is a technical documents containing CMC part – chemistry, Manufacturing & control of an Active pharmaceutical ingredient. Drug master file becomes a part of a registration dossier for finished product registration

RA Docs Provides following service in regards to Drug Master File 

• DMF compilation in CTD Format / Country Specific format.
• Open & close part DMF writing.
• Review of DMF For Submission
• Type II (Active Ingredient) DMF Preparation and submission to US FDA.
• European Certificate of Suitability (CEP) submission and Preparation.
• Canada Submission & Preparation.