Regulatory Strategy with Scientific Input
Regulatory Operations
Need
Approached by Japanese pharmaceutical company with an antiviral product intended to treat and prevent influenza, seeking approval for proof-of-concept (PoC) efficacy clinical study
Assistance required for interactions with European agency to ensure efficient review of protocol and general clinical development plan
Approach
Reviewed non-clinical data and non-clinical development program
Prepared briefing package for scientific advice meeting with national European agency
Liaised with European agency and ensured timely submissions for scientific advice meeting
Coordinated European agency meeting with the client and managed all oral and written communications between the Japanese client and European agency
Benefits
Extensive review of all submission information from the Celerion team enabled on-time and effective input from a European agency on the timing and acceptability of a proof-of-concept efficacy study, and acceptability of development plan allowed quick and immediate go-ahead decision for the client
