Scientific advice is much more than regulatory writing but strategic and scientific work, to judge if results are in line with regulatory requirements and to agree on commitments and investments in the future.
We have the right skills and virtuosity to intertwine development (science), requirements (regulator’s expectations) and exposure (agency interactions) successfully and with the highest benefit to you. Our ex-regulators were among the first experts involved in the scientific advice process of the EMA and by that involved in its conceptual set up. We have conducted numerous scientific advice procedures, both at the agency and at companies’ sides.
We are strong on identifying creative and pragmatic development pathways and to justify gaps in the program or deviations from regulatory guidelines.
To start: In all cases, the identification or challenge of the short-term and long-term development and submission strategy is an important starting point of our support to you. Based on that the questions to be asked to the agencies are identified, often for the immediate interaction but also for future advice procedures.
For all regions, we offer to
- Review the scientific concepts and studies of the CMC, nonclinical and clinical development as compared to the regional regulatory requirements
- Identify the questions
- Write the Briefing Documentation
- Prepare the slides for the agency meeting
- Rehearse the meeting with your team
- Participate in the meeting
- Prepare the meeting minutes
- Interpret the opinions and feedback from authorities
- Identify follow-up strategies
+ Specifics for the EU scientific advice
- Identification of the agencies for the scientific advice – national agencies and/or EMA
- Key messages of the positions of the company – this is development work!
+ Specifics for the FDA pre-IND advice in the US
- Preparation of the answers on the FDA written feedback and of the slides for the agency meeting
- Local agent services as contact point for FDA
+ Specifics for the PMDA consultation in Japan
- Meeting strategy as PMDA typically wishes to split CMC and clinical discussions into separate meetings and prefers to start with CMC
- Identification of time planning to cover all necessary steps of PMDA consultation as PMDA wishes to prepare the consultation process in a pre-consultation meeting to be held on a short notice
- Translation of documents and slides required in Japanese
- Local agent services as contact point for PMDA