Drug Master File(DMF)

drug master file

Enhance your global market access and regulatory success with our comprehensive DMF solutions. Our experienced team specializes in supporting pharma clients for the US, Europe, and emerging markets.

Defining Control Strategy

Strategic definition of control measures for drug substance, ensuring robust quality systems and facilitating regulatory approvals.

CMC Document Review:

Thorough review of Chemistry, Manufacturing and Controls (CMC) documents to ensure accuracy, completeness, and compliance with global regulatory standards. 

NEES/eCTD Compilation

Expert compilation of all DMF sections in both NEES and eCTD formats for efficient electronic submissions and easy regulatory review in line with ICH M4
recommendations.

US DMF and CEP/ASMF Submission

DMF compilation as per US FDA requirements and CEP compilation as per CEP 2.0 guidance requirements. Submission planning ASMF leveraging work-sharing
procedures for streamlined review and simplified life cycle management across EU member states. 

Global DMF Preparation

DMF prepared to meet global regulatory requirements, tailored for CANADA, AUSTRALIA, KOREA, CHINA and emerging markets. We navigate complex country- specific needs for seamless approvals.

Deficiency Anticipation & Life Cycle Management

Anticipate regulatory queries and deficiencies before submission. We support ongoing life cycle management, including updates, variations, and renewals.

Let’s discuss your upcoming project.