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!
Sant Jordi’s Day
Saint Jordi's Day is one of the most original celebrations in Catalonia and takes place on 23 April. This popular festival combines culture and romanticism. On this day, it is custom for couples to exchange gifts...
Invasive Therapies Meeting by EHDN Invasive Therapies Working Group
Next week, our Scientific & Regulatory Affairs Associate Director Christopher Mann will be participating in the Invasive Therapies Meeting organised by European Huntington's Disease Network (EHDN) Invasive Therapies Working Group, in collaboration with SCHD (Stem cells for HD).
CAR T-cell therapy
Are you working in CAR T therapies, advanced therapies or personalised medicine and would like additional regulatory support? Please contact Asphalion at [email protected]
Brexit: Article 50 extension
On 5 April, Theresa May asked EU for Brexit extension and on 11 April, the EU agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 October 2019.
Asphalion participates at the 3rd Annual Meeting of the Myocure project
Asphalion participated in the 3rd Annual Meeting of the H2020 project MYOCURE, the 28th and 29th of March at the Ruprecht-Karls-Universität, in Heidelberg, Germany.
