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!
MISTRAL | EU-funded project to decipher the role of microbiome on HIV pathogenesis and cure
The EU-funded MISTRAL project is exploring the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies.
HONORING PRIDE MONTH
Pride Month commemorates the uprising at the Stonewall Inn back in June 1969. This sparked a liberation movement, a call to action to foster a culture where everyone feels comfortable being their full and authentic selves.
WEBINAR | Quality Management Systems: MDR and IVDR impact
Regulations EU/20174/745 (Medical Device Regulation- MDR) and EU/2017/746 (In Vitro regulation- IVDR) bring requirements for Quality Management Systems.
FORUM INSTITUT COURSE | Marketing authorisation procedures and lifecycle management
ASPHALION experts Lidia Cánovas, Vicente Tur and Ramón Hernández Moratinos, together with other four excellent speakers will share their in-depth knowledge with you and will provide you with practical tips on the requirements for new and existing approvals in Europe.
MEDICAL DEVICE REGULATION (EU) 2017/745 (MDR) | KEY SOLUTIONS PROVIDED BY ASPHALION
ASPHALION experts will help you make sure your device complies with the new MDR requirements.
