
Specialized Standalone or Integrated CMC Regulatory Solutions
The term pharmaceutical CMC stands for chemistry, manufacturing and controls, and is a fundamental requirement of any pharmaceutical application to health regulatory agencies.
EU & US CMC Experts
At Asphalion, we have a team of CMC experts with sound knowledge and experience in a wide range of pharmaceutical forms and types of products:
- Oral, injectable (including freeze-dried) and inhaled solid dosage forms
- Topic, oral, injectable and inhaled liquid dosage forms
- Topic, oral, injectable and inhaled semisolid dosage forms
We can either provide you a full integrated support (from lab to market) or a tailored support as per you specific needs, at any stage of development or during post-approval lifecycle of Human Medicinal Products:
- Innovative (chemical and biological)
- Generics
- Biosimilars
- EU Hybrids / US 505b2
- Well-established use
- Herbal
Our EU & US CMC experts can actively collaborate with you on the following regulatory solutions:
Pharmaceutical Development
- Strategic development and Roadmaps – Integrated with Non-clinical & Clinical development
- Gap analysis at every stage of drug development
- Implementing and managing Quality by Design
- EU IMPD & US IND(A) – writing, review and/or updates
- Dossier writing, review and/or update – EU to US or US to EU
- Due-diligence of in-licensed dossiers
- Expert Reports
- Ad-hoc regulatory strategy
Registrations / Applications
- CTD Mod. 2 and 3 writing, review and/or updates for the EU and US, including:
- EU ASMF and US/RoW DMF.
- Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
- EU MAA (CP, DCP, MRP, NP)
- US IND(A), ANDA and NDA (505b1 and 505b2)
- Dossier gap analysis (Mod. 2.3 and Mod. 3.2.S, 3.2.P and 3.2.R)
- Due-diligence of in-licensing dossiers
- Expert support on responses to Deficiency Letters
- Expert Reports
Maintenance / Lifecycle Management
- CMC regulatory strategy
- CMC Regulatory compliance gap analysis
- Updating dossier sections – strategy, writing and review.
- Variations – strategy, writing, review and/or update of dossier
- Expert support on responses to Deficiency Letters
- CMC Expert Reports (including updates)
- Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) towards eCTD publishing
- Ad-hoc regulatory strategy
Do you need support or more information about the services? Contact us!