Protect Your Product Data with Master File Submissions
Master Files are secure regulatory documents used to protect proprietary product data while supporting approval applications for medical devices, drugs, biologics, and veterinary products.
Registrar Corp helps manufacturers, suppliers, and contract manufacturers submit confidential Master Files to regulatory authorities worldwide, ensuring compliance while safeguarding sensitive information.
2,000+ Medical Device Manufacturers Trust Registrar Corp
Medical Device Master File (MAF) Submissions
An MAF securely shares proprietary device information with regulators — without exposing it to customers or competitors.
What MAFs Include:
- Device formulation & materials
- Manufacturing & sterilization processes
- Packaging, storage, & labeling
- Clinical/non-clinical study data
- Quality control & testing
- Facility & equipment complianceres
Why Submit a MAF?
- Protect Proprietary Information
- Streamline Regulatory Approvals
- Support global market access
Global MAF Submissions with Registrar Corp
Registrar Corp assists medical device manufacturers with secure MAF submissions to:
- United States (US FDA)
- Canada (Health Canada)
- China (NMPA)
- Australia (TGA)
- European Union (CE Marking)
- United Kingdom (MHRA)
- Middle East (Bahrain, Jordan, Kuwait, Oman, Qatar, Saudi Arabia, UAE)
- Africa (South Africa)
- Asia (Thailand, Hungary, Bosnia and Herzegovina)
Drug, Biologics, and Veterinary Master Files
Registrar Corp also assists pharmaceutical, biologic, and veterinary companies with confidential Master File submissions, ensuring compliance with global regulatory agencies.
DMFs/ASMFs (Drug/Active Substance Master Files)
- Drug ingredients & manufacturing
- Packaging & excipients materials
- Facility compliance information
- Drug storage, and stability data
BMFs/BB-MFs (Biologics Master Files)
- Biologic substances & formulations
- Manufacturing & purification processes
- Clinical data & compliance info
- Facility compliance details
VMFs (Veterinary Master Files)
- Veterinary formulations & ingredients
- Manufacturing, packaging details
- Drug storage and stability data
- Regulatory compliance documentation
How Registrar Corp Can Help
Expert Preparation Complete documentation for FDA, Health Canada, EU MDR, and other global regulatory requirements.
Secure Submissions Electronic filing via FDA ESG, Health Canada eSTAR, and CE Marking systems.
Confidential Document Management: Track submissions, Manage amendments, and
Access regulatory documents with full data protection
Protect your data and stay compliant. End-to-end Master File support. Global, precise, compliant.
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