EU Protocol Advice (PA) procedure Featured Image

EU Protocol Advice (PA) procedure

30 Mar 23


  • To obtain EU PA on behalf of a small US-based speciality company focused on developing medicines for rare diseases
  • The prodcuts were classed as ATMPs and were gene therapy for inherited neurological and metabolic syndrome disorders


  • Real Regulatory planned, prepared for, attended, and conducted follow up for an EMA PA procedure
  • Other activities for the same client included ATMP classification; authoring, submission and maintenance of ODD; preparation and submission of PIP application to EMA


  • Procedure completed and advice issued

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