DDReg provides expert consulting and efficient services for quality Drug Substance submissions for US, EU, and other countries. This includes Certificate of Suitability (CEP/COS) submission to the European Directorate for the Quality of Medicines & Healthcare (EDQM). DDReg assists customers for the processes and documentation involved in filing and reviewing the Drug Master File (DMF) or Active Substance Master File (ASMF).
DMFs contain confidential and detailed information regarding API processes, from manufacturing, to the storage of APIs. A CEP is referenced in Marketing Authorization Application after approval by EDQM; it’s an API dossier submitted to EDQM that gives detail on ingredient properties as well as manufacture details to be considered when approving marketing authorization applications in Europe. ASMF is a submission to FDA & European regulatory agencies across Europe respectively providing confidential detailed information about manufacturing processes used during drug substance production at site locations given. This helps to understand ingredients better through data contained therein such as yield calculations.
Following are the services and activities provided by DDReg:
- Writing and submission of ASMF, DMF , and CEP modules
- ASMF, DMF, and CEP Due diligence
- API Documentation audit
- Conversion from CTD/Paper to eCTD
- Module writing for open part and restricted part ASMF/DMF for API, Intermediates as well Semi-finished dosage units.
- Module 1, 2 and 3 for writing for CEP dossier for Quality Check and API.
- API CTD compilation then publishing in eCTD as well as Submission
- Provide assistance in responding to agency queries and to request for more information