Activities

We can provide support, expert advice and contribute with our experience to assist you in a range of pre and post-approval submissions in Europe, USA and in a number of other territories.

EU

  • Pre-submission activities, including but not limited to: invented name applications, eligibility requests, letter of intent to submit an MAA, pre-submission meeting, ATC and INN requests, liaising with the RMS and CMSs, EMA, Rapporteur and Co-Rapporteur, PRIME scheme applications
  • Pediatric Investigation Plans (PIP), waivers or deferrals applications, PIP modifications and PIP compliance checks
  • Marketing Authorisation Applications, including support with the compilation, writing and / or review of every dossier component, including overviews (2.3, 2.4 and 2.5) and summaries (2.6 and 2.7)
  • Marketing Authorisation Transfers (change of ownership) and Withdrawals
  • Variations Type IA, IB, II for CMC and Safety, Grouping and Work sharing
  • Extension Applications
  • Renewals and Annual Renewals (for Conditional MAs)
  • Post-Approval Commitments
  • Other post-authorisation procedures (e.g. Management of sunset clause notifications and requests for waivers, ad-hoc or full support with notification of suspected quality defects or product recalls)

USA

  • Support in the planning and organisation of meetings with the FDA: Type A, B and C, including pre-IND, EoP2 and pre-(A)NDA/BLA, facilities
  • Regulatory support and/or preparation of:
    • Investigational New Drug (IND) applications, including Pre-IND meeting requests and pre-read materials (briefing book)
    • New Drug Applications (NDA) & Biologics Licence Applications (BLA), including pre-NDA and pre-BLA meeting requests and pre-read materials
    • Abbreviated New Drug Applications (ANDA)
    • Orphan Drug Designation (ODD) applications
    • Pediatric Study Plans (PSP)
    • Proprietary Name Review submissions

Rest of the World (RoW)

  • Advise on country-specific requirements
  • Regulatory intelligence and strategic advice
  • Review of submission packages in line with local regulatory guidelines and identification of potential additional data requirements (gap analysis)
  • Regulatory support and/or preparation of country-specific applications in accordance with local requirements
  • Support to perform regulatory submissions and Agency interactions/liaison through locally based regulatory consultants (on-demand)