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Regulatory Services

API documentation and drug master file (DMF) support

Finished-product applicants depend on complete, current information about the active pharmaceutical ingredient. We help API manufacturers prepare drug master files (DMFs), active substance master files (ASMFs) and technical packages that answer applicants’ and authorities’ questions — while protecting confidential process know-how.

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See deliverables
  • Formats US DMF (Type II), EU ASMF, open/closed part DMFs for other markets
  • Typical inputs Route of synthesis, specifications, validation and stability data
  • You receive DMF or ASMF in CTD Module 3.2.S format
Chemistry laboratory bench with reagent bottles and glassware

Overview

About API Documentation & DMF

A DMF allows an API manufacturer to submit confidential information directly to an authority, while the applicant receives only the information it needs. In the EU this is the ASMF, with an applicant’s part and a restricted part. Many other authorities use a similar open-part/closed-part approach.

We prepare the drug substance documentation in CTD Module 3.2.S structure, including impurity discussions aligned with ICH Q3A and M7, and help you keep the file current through annual updates and amendments.

Use cases

When this service helps

First DMF or ASMF filing

Prepare a complete drug substance file for an authority.

Customer requests

Provide an open part or technical package to a finished-product applicant.

Deficiency letters on the DMF

Respond to authority questions about the API.

Changes to the process or site

Prepare amendments and keep the file current.

Scope

What the service covers

  • Drug substance sections 3.2.S.1 to 3.2.S.7
  • Open (applicant’s) and restricted (closed) part separation
  • Impurity discussion including mutagenic impurity and nitrosamine assessment
  • Specification justification and analytical validation summaries
  • Stability data presentation and retest-period justification
  • Letters of access, annual reports and amendments

Who does what

Globaxa prepares the documentation. The DMF holder submits the file (directly or through an agent) and remains responsible for its content and lifecycle.

Should we choose a DMF or a CEP?

For APIs with a European Pharmacopoeia monograph, a CEP can simplify use in many markets that accept it. A DMF or ASMF may still be required for specific authorities. The choice depends on your target markets and customers.

Methodology

How we work

A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.

  1. Review existing dataProcess, controls, validation and stability information.
  2. Map to Module 3.2.SInformation is organised into the CTD structure.
  3. Close gapsMissing data or assessments are identified and planned.
  4. Compile and checkDocuments are written, separated into parts and checked.

Deliverables

What you receive

DMF / ASMF documents

Module 3.2.S sections with open and restricted parts.

Applicant package

Information to support customers’ finished-product dossiers.

Lifecycle documents

Amendments, annual reports and letters of access.

Technical basis

Guidelines we work to

  • ICH M4Q and ICH Q11Structure and content of drug substance information.
  • US DMF regulations21 CFR 314.420; FDA requires DMFs to be submitted in eCTD format.
  • EU ASMF procedureGuideline on the active substance master file procedure (applicant’s and restricted parts).
  • EDQM Certificate of Suitability (CEP)An alternative route for APIs covered by a European Pharmacopoeia monograph.

What we need from you

  • Route of synthesis and process description
  • Specifications for starting materials, intermediates and API
  • Analytical methods and validation reports
  • Process validation and stability data
  • Impurity, residual solvent and elemental impurity assessments

Please share confidential information only after an NDA is in place — we are happy to sign one first.

Market and jurisdiction considerations

The US, EU and many other authorities have formal DMF procedures. In several African and Asian markets, the API information is submitted within the finished-product dossier, sometimes with a closed part sent directly by the manufacturer. We confirm the route for each market.

Related services

Genotoxicity & Impurities

Advanced Impurity Profiling

Systematic identification of actual and potential impurities from the synthetic route, reagents and degradation — the starting point for ICH M7 and Q3A/Q3B.

Regulatory Services

CTD & ACTD Dossiers

Dossiers compiled in ICH CTD or ASEAN ACTD format, adapted to each target market’s regional requirements.

Genotoxicity & Impurities

Genotoxicity Risk Assessment

End-to-end ICH M7 assessments: classification, acceptable intakes, nitrosamine (CPCA) evaluation and control strategies ready for submission.

FAQs

API Documentation & DMF: frequently asked questions

How is confidential process information protected?

Through the restricted (closed) part, which goes to the authority but not to the applicant. We also sign an NDA before receiving process details.

Can you respond to a DMF deficiency letter?

Yes. We help prepare the response and any amendment to the file.

Do you prepare CEP applications?

We can help compile documentation for a CEP application; the application is submitted by the manufacturer to EDQM.

Talk to us about API Documentation & DMF

Share your product, target market and timeline. We will review your requirement and propose a defined scope.

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