Protect your product
data with Master File submissions.
Master Files are secure collections of proprietary product data sent to regulatory bodies around the world in support of drug, biologics, medical device, and veterinary product applications.
At Registrar Corp, we’re committed to helping you keep your confidential information safe and maintain regulatory compliance. We work with drug, biologic, medical device, and veterinary companies to prepare and submit Master Files securely to national and international agencies.
Drug Master Files (DMFs) and Active Substance Master Files (ASMFs)
DMFs and ASMFs, formerly known as European Drug Master Files (EDMFs), provide detailed, proprietary information about human drug products in a secure format.
They may include information on:
- Drug substances and ingredients
- Manufacturing processes
- Packaging materials
- Excipients and preparation materials
- Facilities and their procedures
- Drug storage
- Reference information
Biologics Master files (BMFs/BB-MFs)
BMF or BB-MFs provide detailed, proprietary information about biologics products in a secure format.
They may include information on:
- Drug substances and ingredients
- Manufacturing processes
- Packaging materials
- Excipients and preparation materials
- Facilities and their procedures
- Drug storage
- Reference information
Medical Device Master Files (MAFs)
MAFs provide detailed, proprietary information about medical devices in a secure format.
They may include information on:
- Facilities and their procedures
- Device formulations
- Manufacturing processes
- Packaging materials
- Contract packaging and other manufacturing
- Clinical and non-clinical study data
- Facilities and their procedures
Veterinary Master Files (VMFs)
VMFs provide detailed, proprietary information about veterinary drugs and drug substances in a secure format.
They may include information on:
- Drug substances and ingredients
- Manufacturing processes
- Packaging materials
- Excipients and preparation materials
- Facilities and their procedures
- Drug storage
- Reference information
Submitting your Master Files with Registrar Corp
Companies can leverage Registrar Corp’s Master File Submission Service to safely and securely provide product information to global government agencies.
Our service includes:
Assistance with preparation of Master File submissions and amendments
Conversions of Master File to electronic formats such as electronic common technical document (eCTD) and eCopy
Electronic submission of Master File to requested regulatory agencies such as Electronic Submissions Gateway (ESG) and FDA’s Customer Collaboration Portal (CCP)
Secure online portal to safely access Master File submission documents
Registrar Corp can currently submit your Master Files to agencies in the U.S., Canada, Europe, China, and Australia.
Registrar Corp can assist with all of your Master Files needs.
Complete the form to get started.
Frequently Asked Questions
As part of certain drug and medical device applications to regulatory agencies, a company may need to reference data from another product used in the manufacturing of their own, such as packaging, ingredients, or accessories.
The data’s owner may choose to submit a Master File to disclose proprietary or confidential product information to a regulatory agency without providing it to parties that need to reference it.
Many agencies require submission of Master Files in electronic common technical document (eCTD) format.
Registrar Corp is currently able to submit Master Files to 10 regulatory bodies worldwide.
These include:
- U.S. FDA
- Health Canada
- European Medicines Agency
- Heads of Medicines Agencies such as State Institute for Drug Control Czech Republic or the State Institute for Drug Control Slovak Republic
- United Kingdom (MHRA)
- Chinese National Medical Products Administration (NMPA)
- Australia Therapeutic Goods Administration (TGA)
- European Directorate for Quality of Medicines and HealthCare (EDQM)
- Swissmedic
Type II DMFs (Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product) Type II DMFs comprise 70% of all active DMF filings.
Type III DMFs (Packaging Material) Type III DMFs comprise 20% of all active DMF filings
Type IV DMFs (Excipient, Colorant, Flavor, Essence, or Material Used in their Preparation) Type IV DMFs comprise 8% of all active DMF filings.
Type V DMFs (FDA Accepted Reference Information, Manufacturing Site, Facilities, Operating Procedures, and Personnel) Type V DMFs comprise 2% of all active DMF filings.
Electronic common technical document (eCTD) format is a standard submission format for Master Files.
Agencies such as FDA and Health Canada require eCTD format for certain types of Master File submissions, including DMFs and ASMFs.
eCTD requirements vary by agency. Existing Master Files not in eCTD format, including those in paper form, don’t usually require resubmission to FDA.
However, additional submissions such as annual reports, supplements, and amendments must be submitted to FDA in eCTD.
Health Canada also requires all Master Files to be submitted in an electronic format that may be eCTD.
Some companies prefer to convert their existing paper Master Files to eCTD to expedite the review process of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) that references the Master File.
eCTD submissions must typically be sent through an Electronic Submissions Gateway (ESG).
Access to an agency’s ESG often involves a lengthy application and computer configuration process, a process that may require several weeks of preparation, agency correspondence, and testing.
Alternatively, many companies choose to hire a Regulatory Specialist, such as Registrar Corp, to convert their Master File submissions to eCTD format and submit it on their behalf.