Clinical Development Strategy

Real Regulatory has vast experience with medicinal product development in Europe from small molecule right through to ATMPs.

We are actively advising our clients on development plans, clinical trial strategy and due diligence on FDA packages for suitability for submission to European countries. We also support interactions with the EMAs ITF, gaining SME status, ATMP classifications and certifications, leading SA/PA meetings with EMA and NCA/NRA, authoring and review of documentation for all submissions, including ODD/OMPD, PRIME, PIPs, right through to MAA.  We can provide similar for other country specific schemes for early access and assistance with development strategy.

We are also actively providing hands-on support of Clinical Trial submissions for trial phases I through III throughout the whole of Europe for both NCA/NRA and EC approvals, and supporting trials in other global markets.

Services include

  • Provision of a flexible virtual development team from our panel of European subject matter experts
  • Provision of an EU based legal entity to access SME fee incentives at EMA for 3rd country SME clients
  • Advice on preparation of your Clinical Development Plan and Target Product Profile
  • Due diligence review of 3rd country clinical, non-clinical and CMC packages and data for suitability for submission in Europe
  • Authoring, preparing, submitting and leading Scientific Advice, Orphan Designation and Paediatric Investigation Plan processes with EMA and individual national agencies, as appropriate
  • Authoring of IMPDs and MAAs
  • Supporting interactions with the EMA Innovation Task Force or equivalent National Agency schemes
  • Preparation of your e-CTD Marketing Authorisation Application in Europe

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