K R I D H A P H A R M A

KRIDHA PHARMA

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Drug Marster File

DMF

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 info@kridhapharma.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 provide DMF in ACTD format.

  • Table of Contents
  • CTD Introduction
  • Quality Overall Summary
  • S.1 General Information
  • S.2 Manufacture (ROS)
  • S.3 Characterization
  • 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 Authorization & 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, Analytical Method 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 have extensive experience in DMF preparation and review.
  • Our consultants have previously worked in top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin, and more.
  • Handling all Ministry of Health (MoH) Queries related to DMF (up to product registration).
  • DMF review in compliance with CTD (Common Technical Document) standards.
  • Offering over 1200 CTD DMF templates (Ready-to-use) to save time.
  • Providing reference DMFs from the US and EU – a collection of 600 DMFs.

Prepare, Review And Submit

Format: CTD (Common Technical Document)

Upon request, we can also provide 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 have vast experience in DMF preparation and review.
  • Our consultants have previously worked in top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin, and more.
  • Handling all Ministry of Health (MoH) Queries related to DMF (up to product registration).
  • DMF review in compliance with CTD (Common Technical Document) standards.
  • Offering more than 1200 CTD DMF templates (Ready-to-use) for time-saving convenience.
  • Providing a reference collection of 600 DMFs from the US and EU.

Writing / Review

  • Registration Application, Letter of Authorization & 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, Analytical Method Validation (AMV) & Stability Studies
  • Specification, Method of Analysis & Certificate of Analysis of Raw Materials
  • Specification, Method of Analysis & Certificate of Analysis of API

Quality

  • Delivering exceptional quality at affordable rates
  • Ensuring confidentiality and on-time delivery
  • Providing a comprehensive DMF solution

Team

  • Regulatory Proficiency - A Team of 11 Dedicated DMF Professionals with Extensive Knowledge and Experience
  • Comprehensive Regulatory Support for DMF Queries up to Product Registration
  • Over 8 Years of Expertise in Global Regulatory Environments Since 2011

In-house Facility

  • Our Regulatory Affairs Service Facility Spans 4,500 Square Feet
  • Equipped with State-of-the-Art and Highly Advanced Instruments
  • Utilizing a High-Quality Database with Templates and Reference DMFs