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