Chemistry Manufacturing and Controls (CMC)
Regulatory Support
CMC Regulatory support at every stage of development, registration and life cycle management.
BlueReg experts will provide your company with CMC Regulatory support at every stage of the development.
- Assessment / definition of the CMC development strategy
- Writing of CMC sections of briefing books for health authorities meetings
- Assessment / preparation of regulatory documents:
- Investigational New Drug (IND) application
- Investigational Medicinal Product Dossier (IMPD)
- Active Substance Master File (ASMF) / Drug Master File (DMF)
- Certificate of Suitability to the European Pharmacopeia (CEP)
- Responses to agency questions
Our experts
Our team can also support you through the entire application process from development, to registration and post-approval management
Associated News
How antibody testing can help us fight COVID-19 ?
There is a high demand around the need for antibody testing and the media frenzy...
Nitrosamine impurities – are you ready to fulfil your legal obligations as a MAH by March 26th, 2020?
During the summer 2018, authorities become aware of the presence of some nitrosamines in API...
CPHI Worldwide in Frankfurt
BlueReg Team will attend the CPHI Worldwide in Frankfurt, from November 5 to 7. Our...