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Drug Marster File (DMFs)

MYdossier is a global leader in regulatory consulting and DMFs solution for export registration. We write and review Drug Master File (DMFs) as per European CTD / ASEAN CTD / non-CTD (country specific guideline).We can also prepare Techincal Pack of APIs and Bulk Drugs.

Administrative Documentation (Writing and Review):-
- Registration Application, Letter of Authorisation & Covering Letter
- Legal & Administrative Documents
- Transmittal letter
- Global Patent Information and Literature for patented API
- Patent infringement analysis

Technical Documentation (Writing and Review):-
- Summaries - Quality (2.3.S part)
- Drug master file (open and closed part)
- Manufacturing and Characterization part of DMF
- Process validation, AMV & Stability Studies
- Specification, Method of analysis & Certificate of Analysis of Raw materials
- Specification, Method of analysis & Certificate of Analysis of API

We had prepared more than 1850 DMFs. We can also prepared S-Part of CTD for formulation dossier submission (CTD / ACTD).

We can assure you that our prepared DMFs will help you for product registration & we will support upto final registration. And we will handle all MOH queries (if needed).

About us

MYdossier (Division of Zodiac Pharma) is an Indian based Export dossier registration consulting firm. 

Mission: "To become a Research-based International Regulatory Affairs and dossier development centre"

Core Values : We are driven by a desire to excel and exceed customer expectations, provide a joyous working environment for our people and empower them to think big and set ambitious goals. We want to achieve all this in an environment that promotes integrity.

Vision: "Achieving significant business in generic product dossier consultancy with a strong presence in non-regulated and semi-regulated market (Asia, Africa, CIS, Latin America)"

Customer Focus Drive : Customer satisfaction is an expectation that we have built in our markets and we are always looking for new ways to meet and exceed our customers' needs and expectations.

Reliability : With reliability comes expectation with expectation comes dependence. We at Zodiac Pharma pride ourselves on the fact that our customers rely on us for the highest standard services.

Quality : All our business practices and services are a hallmark of MYdossier. We aim and succeed in achieving a quality outcome in every avenue of business that we pursue with an unrelenting ambition.