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!
EU ISO IDMP Implementation Guideline – V1
Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).
Asphalion & Magic Line 2020
On March 1st Asphalion will join the solidarity march for the Hospital Sant Joan de Déu: La Magic Line.
Pharmacovigilance and Regulatory services in the UK
As of 1 February 2020, the United Kingdom (UK) is no longer an EU Member State and acts as a third country. This means that the UK no longer participates in EU institutions and their decision-making.
Today is the International Day of Women and Girls in Science
At Asphalion we work together with our clients to generate ideas and implement solutions that contribute to improve people's quality of life.
AsphaNews 2020 | First Newsletter of the year
Welcome back! Check out the first newsletter of the year to keep up to date with the latest news and events on the regulatory affairs and pharma sector!
