Drug Marster File
Open & Closed Part - DMF
We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline)
Email your DMF requirements to dhaarmi@fidesregulatory.com/ fidesraa@gmail.com - We will review your requirements and revert back to you ASAP. And will also provide Quote / sample DMF Index on demand
PREPARE, REVIEW AND SUBMIT
Format : CTD (Common Technical Document)
Upon request we can also give DMF in ACTD format
Table of content
CTD Introduction
Quality Overall Summary
S.1 General Information
S.2 Manufacture (ROS)
S.3 Characterisation
S.4 Control of Drug Substance
S.5 Reference Standards or Materials
S.6 Container Closure System
S.7 Stability
WRITING / REVIEW
- Registration Application, Letter of Authorisation & Covering Letter
- Legal & Administrative Documents
- Transmittal letter
- Global Patent Information and Literature for patented API
- Patent infringement analysis
- Quality Summaries, 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
ADVANTAGES OF OUR CONSULTANCY
- Experienced Team – Our consultants had vast experience in DMF preparation and review
- Our consultants - previously worked in Top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc
-Handling all MoH Queries related to DMF (till product registration)
- DMF review as per CTD
- More than 1200 CTD DMF templates
(Ready-to-write : to save time)
- Reference US & EU – 600 DMFs
PREPARE, REVIEW AND SUBMIT
Format : CTD (Common Technical Document)
Upon request we can also give DMF in ACTD format
S.2 Manufacture
S.2.1 Manufacturer (s)
S.2.2 Description of Manufacturing Process and Process Controls
S.2.3 Control of Materials
S.2.4 Controls of Critical Steps and Intermediates
S.2.5 Process Validation and/or Evaluation
S.2.6 Manufacturing Process Development
ADVANTAGES OF OUR CONSULTANCY
- Experienced Team – Our consultants had vast experience in DMF preparation and review
- Our consultants - previously worked in Top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc
-Handling all MoH Queries related to DMF (till product registration)
- DMF review as per CTD
- More than 1200 CTD DMF templates
(Ready-to-write : to save time)
- Reference US & EU – 600 DMFs I
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
- Quality Summaries, 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
QUALITY
- Highest quality @ reasonable price
- Confidentiality and On-time delivery
- Complete DMF solution
TEAM
- Regulatory expertise -Dedicated DMF professionals (Knowledgeable & Experienced 11 people)
- Complete regulatory assistance on DMF queries upto the product registration stage
- Since 2011, Over 8 years of experience in global regulatory environments
IN-HOUSE FACILITY
- Our regulatory affairs (Dossier & DMF) service facility Area is about 4500 feet
- We have most Advance and Sophisticated equipment
- High quality Database (Template & reference DMF)
