At Asphalion, we have a 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 that can actively collaborate with you on:

• PHARMACEUTICAL DEVELOPMENT
  • Development strategy and Roadmaps – Integrated with Non-clinical & Clinical development
  • Gap analysis at every stage of 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
  • 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
  • Expert Reports (including updates)
  • Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) towards eCTD publishing
  • Ad-hoc regulatory strategy