Effective regulatory plans require frequent communication with a number of Health Authorities in many different countries on topics such as:
- Scientific advice: conducting scientific advice to ensure key questions are adequately addressed at important milestones such as First Human Dose, End of Phase II and Presubmission meetings
- Day to day dialogue related to clinical trials, maintaining regulatory dossiers, updating plans to keep Regulatory Authorities up to date with your medicines development programmes etc.
- Label negotiations
- Advisory Committee Meetings with the US FDA
Support to developing briefing documents for effective scientific advice, identifying potential questions from Health Authorities, interpreting the Health Authority feedback and strategies for addressing questions and conducting rehearsals.
Effective regulatory plans require frequent communication with a number of Health Authorities in many different countries on topics such as:
- Scientific advice: conducting scientific advice to ensure key questions are adequately addressed at important milestones such as First Human Dose, End of Phase II and Presubmission meetings
- Day to day dialogue related to clinical trials, maintaining regulatory dossiers, updating plans to keep Regulatory Authorities up to date with your medicines development programmes etc.
- Label negotiations
- Advisory Committee Meetings with the US FDA
Support to developing briefing documents for effective scientific advice, identifying potential questions from Health Authorities, interpreting the Health Authority feedback and strategies for addressing questions and conducting rehearsals.