Marketing Authorization, Dossier & Regulatory Affairs

PrimeGMP provides end-to-end regulatory support for global submissions, dossier preparation, lifecycle management, and marketing authorization activities. We help pharmaceutical manufacturers navigate regional and international requirements, ensuring faster approvals, compliant documentation, and seamless communication with regulatory agencies.

Our Core Regulatory Services

1. Gap Analysis of Existing Documentation

Comprehensive review of current technical files, dossiers, and supporting documents to identify deficiencies and compliance gaps.

2. Regulatory Strategy & Submission Planning

Tailored regulatory roadmaps for USFDA, EMA, MHRA, TGA, WHO, GCC, and ROW markets — including accelerated, standard, and variation pathways.

3. CTD / eCTD Dossier Preparation (Modules 1–5)

Preparation, compilation, formatting, and publishing of complete CTD/eCTD submissions aligned with global requirements.

4. CMC (Chemistry, Manufacturing & Controls) Writing

Robust and audit-ready CMC documentation covering product development, manufacturing, process validation, and quality controls.

5. Drug Master File (DMF/ASMF) Compilation

Complete DMF/ASMF preparation including Part I/II, LoA management, updates, and regulatory communication.

6. Response Management for Regulatory Queries

Preparation of scientific and regulatory responses addressing deficiencies, observations, and clarification requests from authorities.

7. Labeling & Artwork Regulatory Review

Regulatory-compliant review of labels, cartons, inserts, and promotional materials for accuracy and compliance with regional requirements.

8. Variation Filing & Lifecycle Management

Management of post-approval variations, renewals, periodic safety updates, and dossier maintenance across global markets.

9. Global Market Registration Support

End-to-end support for product registration across emerging and ROW markets, including compilation, submission, and regulatory coordination.

10. Audit Support & Regulatory Readiness

Assistance during regulatory inspections — documentation readiness, training, mock audits, CAPA support, and post-inspection responses.