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Regulatory Affairs Services

We can assist with all aspects of regulatory procedures from development through to commercialisation and life cycle management. Our services include authoring, preparing and filing applications, integrating with your in-house teams to advise on EU and global regulatory requirements, liaising with Regulatory Authorities on your behalf. The areas we can assist you with include:

Clinical Trial Applications:

  • New CTA or IND submissions in EU, Europe & US
  • Manage agency interactions and act as EU representative
  • Authoring and review of IMPD (Investigational Medicinal Product Dossier)
  • Substantial amendment, end of trial notification, study report submissions
  • Orphan drug designation applications
  • SME (micro, small and medium-sized enterprises) application

 

Expert Report Writing:

  • Quality Overall Summaries
  • ASMF (active substance master file) updates
  • Biosimilarity Assessment Reports for biosimilar MAAs
  • Preparation and review of Module 3

 

Marketing Authorisation Applications:

  • Marketing Authorisation Applications (MAA):
    • National Procedures
    • Decentralised (DCP) and Mutual Recognition (MRP) Procedure
    • Centralised Procedure
  • New Drug Application(NDA)/Biologics Licence Application (BLA)
  • Full regulatory technical support
  • Liaison support with EU Health Authorities (NCAs, EMA) and FDA.

 

Life Cycle Management:

Post-approval, we will support the maintenance and life cycle management of your products:

  • Variations
  • Renewals
  • Line extensions
  • PSUR (periodic safety update report) submissions
  • Commitment tracking and follow-up
  • Response to Agency requests