Specialized standalone or integrated CMC solutions
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
- CTD Mod. 2 and 3 writing, review and/or updates for the EU and US, including:
- 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
Do you need support or more information about the services? Contact us!
Q&A document on the implementation of the MDR and IVDR
The EMA has recently revised the Q&A document that provides practical considerations concerning the implementation of the MDR and IVDR.
Graphene Connect on MedTech and Diagnostic Technologies
Yesterday, November 6, Dominique Monferrer and Eduardo Garrido participated in the event Graphene Connect on MedTech and Diagnostic Technologies associated with the first Graphene for Health Investment Forum.
Brexit | Very interesting and productive day!
Last week, Lidia Cánovas and Nuria Romero participated in the seminar “Els efectes del Brexit en el sector Farma".
La Castanyada & Halloween in Asphalion
Asphalion is celebrating both events on the same day. Do you celebrate these festivities in your company too? Trick or Treat?
Training session on regulatory approach of ICH Q12
Yesterday, Consol Bozzo Mulet and Daniel Langa García gave a training session on regulatory approach of "ICH Q12: Control de cambios. Consideraciones técnicas y regulatorias en el ciclo de vida de los productos farmacéuticos.”.
