DMF Writing and Management

We offer end-to-end support for Drug Master File (DMF) lifecycle management, ensuring full compliance with FDA and international regulatory expectations.

Our comprehensive USDMF services

• DMF Due Diligence & Gap Analysis
  Thorough evaluation of technical and regulatory aspects to ensure completeness and compliance before submission or reference.

• DMF Audit Support
  Internal audits or supplier audits to verify data integrity, quality systems, and readiness for regulatory inspection.

• DMF Writing & Compilation
  Preparation and authoring of :

  • Module 1: Regional administrative information

  • Module 2: Summaries (including QOS in QbR format)

  • Module 3: Quality documentation

• Pre-assigned DMF Number Application
  Submission to USFDA to obtain pre-assigned DMF numbers before formal filing.

• Regulatory Strategy and Consulting
  Guidance on optimal DMF structuring, global acceptance strategy, and regulatory pathways.

DMF Lifecycle Management

Timely filing of annual updates and compliance maintenance as required by regulatory authorities.

• DMF Amendments
  Preparation and submission of amendments for changes in manufacturing process, specifications, or other significant updates.
  

• Query Response Support
  Assistance in drafting responses to:

  • FDA Requests for Additional Information (RFI)

  • ANDA/NDA/BLA application references

  • Refuse to File (RTF) communications

Our Services Include:

Gap Assessment & Due Diligence

• Detailed evaluation of technical documents and existing data against current EDQM and Ph. Eur. requirements.

• Identification of gaps in quality, specifications, or manufacturing controls that may delay approval.

CEP Dossier Preparation (CTD Format)

• Authoring and compilation of complete Module 3 (Quality) as per EDQM’s requirements:

  • 3.2.S Sections covering:

    • Manufacturing process

    • Control of materials

    • Process validation

    • Impurity profile and control

    • Stability data

• Preparation of Quality Overall Summary (QOS)

• Ensuring compliance with ICH guidelines, Ph. Eur. general chapters, and monograph-specific requirements

RGInsight provides complete support for obtaining a Certificate of Suitability (CEP) through the EDQM, ensuring that your API complies with the relevant European Pharmacopoeia (Ph. Eur.) monograph.

The CEP pathway is widely accepted across Europe and in many other global markets, streamlining the API qualification process for Marketing Authorization Applications (MAAs).

CEP Dossier Preparation & Regulatory Support

CEP Lifecycle Management

• CEP Lifecycle Management

  • Preparation and submission of:

    • Revisions for changes in manufacturing process, site, or controls

    • Notifications (Type IA/IB equivalent)

    • Renewals of CEP certificates/Sister CEPs

• Support in implementing EDQM’s CEP 2.0 standards (new format and content expectations)
  

• Post-Submission Support

  • Response to Requests for Information (RFI) and deficiency letters from EDQM/USFDA

  • Strategic guidance to address critical issues, such as impurity profile mismatches, changes in synthetic route, or specification gaps

  • Timely communication with Health Authorities to avoid delays

Global Utility of CEP

• Guidance on using the granted CEP in EU centralized, DCP, MRP, and national MAAs

• Advice on leveraging CEP in non-EU countries (e.g., GCC, MENA, LATAM) that accept EDQM approvals

ASMF Writing and Submission

Our comprehensive ASMF services include:

1. ASMF Due Diligence & Audit

• Comprehensive review of existing ASMFs

• Gap analysis to ensure compliance with current regulatory requirements

• Risk assessment for technical and regulatory deficiencies
  

2. ASMF Module Writing

We specialize in writing complete ASMFs including:

• Module 1: Regional administrative and product-specific information

• Module 2: Quality Overall Summary (QOS)

• Module 3: Comprehensive technical data for:

  • Active Pharmaceutical Ingredients (API)

  • Intermediates

  • Semi-finished Dosage Forms
    

We prepare both:

• Applicant’s Part (Open Part)

• Restricted Part (Closed Part)

Regulatory Strategy and Consulting
Guidance on optimal DMF structuring, global acceptance strategy, and regulatory pathways.

At RGI, we offer end-to-end support for the preparation, compilation, and submission of Active Substance Master Files (ASMFs). Our expertise ensures full regulatory compliance, seamless submissions, and faster approvals for your Active Pharmaceutical Ingredients (APIs), intermediates, and semi-finished products.

What is the ASMF Procedure?

The ASMF (formerly known as EDMF) procedure is designed to protect the intellectual property of the API manufacturer while allowing health authorities to assess the safety, quality, and control of the substance.

The ASMF procedure can be used for the following active substances:

• New active substances

• Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State

• Pharmacopoeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State

• Herbal active substances/preparations (as long as they are not biological in nature)

Note: The ASMF procedure is not applicable for biological active substances.

ASMF Lifecycle Management

We offer end-to-end support for the complete lifecycle of Active Substance Master Files (ASMFs) to ensure regulatory compliance and timely approvals across global markets.

• ASMF Preparation & Submission: Comprehensive writing and formatting of ASMFs in CTD/eCTD format as per EU, UK, WHO, and other regulatory authority requirements.

• Regulatory Gap Analysis: Evaluation of existing ASMFs against current guidelines to identify and address deficiencies before submission or updates.

• Change Management & Amendments: Assistance in implementing post-approval changes, submitting amendments, and maintaining version control.

• Query Response & Communication Support: Expert handling of regulatory queries and seamless coordination with stakeholders, including applicants and authorities.

• Annual Updates & Maintenance: Timely preparation of annual reports and proactive updates to keep the ASMF current and in compliance.

With our deep regulatory expertise, we ensure your ASMF remains compliant and strategically aligned throughout its lifecycle.

eCTD Publishing & Submission

• Conversion of CEP/DMF/ASMF dossier into fully validated eCTD format

• Publishing with appropriate granularity and metadata

• Full publishing in eCTD format

• Submission through CESP portal and through the FDA’s Electronic Submissions Gateway (ESG).