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DMF Services

 INDIA'S MOST RELIABLE & RECOMMENDED
DMF PROVIDER

Zodiac Pharma is a Global Leader in Regulatory Consulting and DMF (CTD, ACTD & Tech Pack) Solution 

Drug Marster File

Open & Closed Part - DMF

Email your DMF requirements to info@zodiacpharma.com - We will review your requirements and revert back to you ASAP. And will also provide sample documents 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)
- Complete regulatory assistance on DMF queries upto the product registration stage
- Since 2008, Over 11 years of experience in global regulatory environments

IN-HOUSE FACILITY

- Our regulatory affairs (Dossier & DMF) service facility Area is about 30,000 sft at APIIC, Madanapalle, AP.
- We have most Advance and Sophisticated equipment
- High quality Database (Template & reference DMF)

MOBILE FRIENDLY

No special actions required, all sites you make with Mobirise are mobile-friendly. You don't have to create a special mobile version of your site, it will adapt automagically.

MOBILE FRIENDLY

No special actions required, all sites you make with Mobirise are mobile-friendly. You don't have to create a special mobile version of your site, it will adapt automagically.

MOBILE FRIENDLY

No special actions required, all sites you make with Mobirise are mobile-friendly. You don't have to create a special mobile version of your site, it will adapt automagically.

IT'S EASY AND SIMPLE

Cut down the development time with drag-and-drop website builder. Drop the blocks into the page, edit content inline and publish - no technical skills required.

IT'S EASY AND SIMPLE

Cut down the development time with drag-and-drop website builder. Drop the blocks into the page, edit content inline and publish - no technical skills required.

IT'S EASY AND SIMPLE

Cut down the development time with drag-and-drop website builder. Drop the blocks into the page, edit content inline and publish - no technical skills required.

TRENDY WEBSITE BLOCKS

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Choose from the large selection pre-made blocks - full-screen intro, bootstrap carousel, slider, responsive image gallery with, parallax scrolling, sticky header and more.

TRENDY WEBSITE BLOCKS

Choose from the large selection pre-made blocks - full-screen intro, bootstrap carousel, slider, responsive image gallery with, parallax scrolling, sticky header and more.

Our Happy Clients

More than 120 Satisfied Global Clients

Address


Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, IN

GSTN: 37AAAFZ9801C1Z7

Contact Us &  Enquiry Form

Email: info@zodiacpharma.com Phone: +91 - 832 847 9767
+91 - 965 228 1814
Web: www.zodiacpharma.com 

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About us & Team