Ivowen provides the following services to pharmaceutical companies:
- Act as MAH
- Regulatory Strategy
- National Procedures
- Decentralised (DCP) and Mutual Recognition (MRP) Procedures
- Centralised Procedures
- eCTD preparation and validation (MAA submissions; ASMF updates)
- Paediatric Investigation Plans (PIPs) & Paediatric Use Marketing Authorisations (PUMAs)
- Variations and Renewals
- Quality Overall Summaries
- Clinical Trial Applications
- Clinical and Non-clinical experts
- Environmental Risk Assessment experts
- Biowaiver experts
- Toxicology experts
- Dossier audits
Ivowen participates in EuDRAcon, a pan-European network of regulatory affairs consultancy companies, dealing with drugs, medical devices, cosmetics and food supplements, ensuring access to expert local knowledge in our clients’ target markets.
