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!
Digital transformation and pharmacovigilance: technology update
Today, our experts Núria Romero, Sonia López, Nuria Cabello and Bernat Autonell participated in the workshop “Digital transformation and pharmacovigilance: technology update” organized by Arithmos, Asphalion and Oracle Health Sciences.
Marcos Fernandez is attending the LORENZ userBridge Conference 2019
Today Marcos Fernandez, Regulatory Affairs Manager at Asphalion, is attending the LORENZ userBridge Conference 2019 in Greece.
Luxturna: the first licensed gene therapy for rare inherited eye disorder is recommended by NICE
A draft NICE guidance recommends Voretigene Neparvovec (also called Luxturna) to treat people with vision loss caused by inherited retinal dystrophy from confirmed RPE65 gene mutations who have enough viable retinal cells.
FDA aims to start deactivating outdated drug listing records to ensure the patient safety
The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records.
New study shows EMA and FDA aligned on marketing authorisations
The FDA and the EMA are aligned in more than 90% of marketing authorizations (MA) for new drugs, according to a new study from EMA and FDA officials comparing 107 new medicine applications at the two agencies between 2014 and 2016.
