Drug Master Files (DMFs)

Type II – Active Pharmaceutical Ingredients (APIs)

Type III – Packaging Materials

Type IV – Excipients

PharmaReg offers full range of regulatory support for API and Component Suppliers. Our services include:

• Authoring Open & Close Parts of DMF

• DMF Completeness Review per FDA Requirements

• eCTD Compilation and Submission to FDA

• Lifecycle Management including Amendments and Annual Reports

• Requesting Pre-assigned DMF numbers

• US Agent Services to Facilitate FDA Communications