Regulatory Affairs

We support clients to develop a clear regulatory strategy enabling them to develop their drugs as efficiently as possible. We have experience across a range of drug types including small molecules, biologics and drug-device combinations. We understand the specific regulatory requirements in the US, Europe and Japan enabling us to support our clients ranging from biotech start-ups to mid-sized pharmaceutical companies.

  • Tailored regulatory strategy from early development through to market approval
  • Gap analysis of existing and planned data
  • Drug-device combination strategy
  • Optimisation of approach to Regulatory Agency consultation (FDA meetings, EMA scientific advice, PMDA consultation)
  • Identify opportunities for Expedited Pathways
  • Regulatory Due Diligence reviews
  • Regulatory Intelligence
  • Experience with FDA, EMA and EU National Authorities, MHRA (UK) and PMDA (Japan)
  • Strategy, planning and submission
  • Meeting requests and briefing packages
  • Meeting preparation, management, attendance and minutes
  • Regulatory authority communications
  • SME incentives through Artemida Pharma Europe Limited
  • Legal Representative/US IND agent/Local contact
  • Paediatric Plans (PIP/PSP)
  • Orphan Drug Designations
  • Regulatory Agency Advice and Meetings
    • EU, UK and National Authority Scientific Advice
    • FDA Pre-IND, EOP2, Pre-NDA/BLA and other meetings
  • Clinical Trial Applications (CTA/IND)
  • Marketing Applications (MAA/NDA/BLA) and Lifecycle Maintenance
  • Expedited Pathways
    • US Fast Track, Breakthrough Therapy Designation, Accelerated Approval and Priority Review designation
    • EU PRIME, Accelerated Assessment
    • UK Early Access to Medicines Scheme (EAMS), Promising Innovative Medicine (PIM)
  • Advanced Therapy Classification
    • US Regenerative Medicine Advance Therapy Designation (RMAT)
    • EU Advance Therapy Medicinal Product Designation (ATMP)
  • Dossier preparation, publishing and submission
  • Regulatory authority meeting requests and briefing packages
  • Clinical Trial Applications (CTA/IND, IMPD etc)
  • Paediatric Plans (PIP, PSP)
  • Orphan Drug Applications
  • Marketing Applications (MAA/NDA)
  • Clinical and Non-Clinical Overviews and Summaries
  • CMC Dossiers