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Advancements in nuclear medicine technology is expected to represent a key strategic factor in opening up new clinical opportunities for radiopharmaceutical agents. The increase of imaging procedures is leading to higher regulatory requirement specific to radiopharmaceuticals. We analyze the USA FDA dossier to be submitted in the EU.

PNS Services include :

  • Regulatory consultancy and development plan

  • Full support for responses to warning letters, inspection and all related matters

  • Preparation for meeting with authority when required

  • Quality-Audit services : Procedures GAP analysis, Audit/Mock inspection, QMS, CAPA, TMF... 

Right regulatory support :

Marketing Authorization Application (MAA) :

  • Management of the full eCDT dossier or help for a portal submission in case of MRP

  • Initial Submission

  • Maintenance of marketing authorization (renewals, line extension…)

  • Handling of linguistic review of product information for all EU countries

Clinical Trial applications :

  • Advices on requirements including the review of full pre-clinical dossier for Internal Vectorized Radiotherapy

  • Submission to Competent Authorities

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