Pharmaceuticals (Human & Veterinary)

Ivowen Limited 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

Ivowen Limited 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.


eudracon

 

 

pharma med-devices pharma-vigilance training