Drug Master File (DMF)
SciRegs International Inc. provides comprehensive regulatory support for Drug Master Files (DMFs), including Type II Drug Substance DMFs and Type III Container Closure System DMFs. We help DMF holders and applicants prepare, submit, and maintain FDA‑compliant DMFs with accuracy, consistency, and confidence.
Our experienced regulatory professionals manage both the technical and procedural aspects of DMF submissions, ensuring alignment with FDA and ICH requirements while supporting efficient lifecycle management.
SciRegs®
SciRegs® partners with clients to reduce regulatory risk, maintain DMF compliance, and support timely access to referenced information throughout the product lifecycle.
DMF Support Services
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DMF submission audits to assess submission readiness and regulatory compliance
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Annual report preparation and support
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Letters of Authorization (LOA) preparation and submission
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Compilation and preparation of DMF submission content
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CTD structuring in accordance with FDA and ICH requirements
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Electronic CTD (eCTD) creation and submission, including full lifecycle management