Managing DMFs or ASMFs Worldwide?
We Make It Easy
Struggling to protect proprietary DMF or ASMF data while supporting partner submissions?
A Drug Master File lets regulators access key information, without disclosure. But preparing one for FDA, EMA, or PMDA demands precision. Registrar Corp simplifies the process with expert support from start to submission. Stay compliant and globally ready, minus the guesswork.
3,000+ Drug Manufacturers Trust Registrar Corp
What Is a Master File and Why It Matters
A Master File is a confidential dossier submitted to regulatory authorities containing detailed information about manufacturing, composition, quality controls, and more. Its primary function is to protect intellectual property while facilitating regulatory submissions by partner companies.
Whether you’re a contract manufacturer, API supplier, packaging developer, or excipient innovator, a Master File lets your clients cite your data in their market applications—without duplicating or exposing your sensitive documentation.
Registrar Corp supports:
Drug Master Files (DMFs)
Types I to V for U.S. FDA
Japan DMFs (J-DMFs)
For submissions to PMDA
Veterinary Master Files (VMFs)
Animal drug markets
Canadian DMFs
Under Health Canada’s requirements
Active Substance Master Files (ASMFs)
For EMA and global markets
China CDE DMFs
In support of NMPA filings
Our Full-Scope Drug Master File Services
Registrar Corp delivers end-to-end support for Master File development, submission, and maintenance. Our experts specialize in regulatory documentation, data protection strategies, and jurisdiction-specific formatting standards.
Our Process Includes
Data Compilation &
Risk Review
Data Compilation & Risk Review. Your data is assessed for regulatory completeness, confidentiality alignment, and risk exposure.
Regulatory Strategy &
Jurisdiction Mapping
We determine which type of Master File is needed for each market and help prioritize submissions based on your commercial objectives.
Global Submission &
Authority Correspondence
We handle technical transmission (e.g., FDA ESG, EMA CESP), manage validation issues, and respond to regulator feedback or queries.
Document Authoring &
Technical Formatting
Submissions are prepared according to eCTD, NeeS, or other required formats for each authority, including narrative components and Module 3 alignment.
Annual Reports, Amendments
& Lifecycle Updates
We manage required renewals, content updates, and authority notifications to keep your files current and compliant.
Letter of Access /
Authorization Management
We generate and track LOAs or access authorizations for all referencing companies, ensuring proper linkage to your file.
Common Challenges We Help Solve
Unstructured or incomplete submissions leading to regulatory rejection
Improper access controls or missing authorization letters
Format incompatibility with eCTD, NeeS, or emerging systems
Missed jurisdiction-specific lifecycle updates or report schedules
Insufficient confidentiality protection risking IP exposure
Why Global Companies Choose Registrar Corp?
20+ Years Regulatory
Experience Trusted by
over 30,000 regulated
companies
Dedicated Account
Coordination One
point of contact, full
lifecycle support
Technical Submission
Mastery eCTD, ESG, CESP,
and other gateways
handled end-to-end
Multi-Jurisdiction
Expertise. We serve
US, EU, Canada,
Asia-Pacific & LATAM
Confidentiality-First
Approach. Your data is
secure and protected
at
every step
Industry Breadth APIs,
excipients, packaging,
finished products, and
veterinary files
Regulatory compliance is just the baseline. A well-prepared Drug Master File positions your company as a reliable, globally ready partner. Let Registrar Corp help you open new markets, protect trade secrets, and build trust with clients worldwide.
Your Master File Is More Than a
Document — It’s a Strategic Asset
Contact Us
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