Master Files (ASMF, DMF, PMF), CEP

Exalon supports manufacturers (of drug substances, packaging materials, excipients etc.) in the eCTD publishing and submission of their dossiers:

• ASMF (Active Substance Master Files)
• DMF (Drug Master Files)
• PMF (Plasma Master Files)
• CEP (Certificates of Suitability)

Exalon offers an assessment of your documentation and recommendations on aspects such as eCTD readiness, approach for baselines submissions or multi-regional submissions (EU). Among others Exalon has a broad experience with DMFs for Packaging Materials (e.g. US Type III DMF, CA Type II DMF) – we provide advice on eCTD structure for multi-item packaging materials (based on authority recommendations and best-practice) and support adaptation of source documents.