Preparation of EU PIP application Featured Image

Preparation of EU PIP application

05 Apr 23


  • Small US-based speciality company focused on developing medicines for rare genetic diseases. The products are classed as ATMPs and are gene therapy products for inherited neurological and metabolic syndrome disorders
  • Preparation and submission of an EU PIP application, including all EMA interactions
  • The product is a gene therapy product that does not fit precisely into the traditional categories of products


  • All support is provided remotely, except for required attendance at agency meetings
  • Plan timeframes according to EMA published timelines
  • Advise client regarding EMA PIP application requirements
  • Prepare PIP application documents for client review
  • Liaise with EMA re: validation issues and the adoption of PDCO opinion/PDCO request for modification


  • Successful submission of the PIP for this unusual gene therapy product to the EMA

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