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Capabilities
- Development or assessment of strategy
- Evaluation of potential program(s)
- Selection of initial or subsequent disease targets
- Development of clinical and regulatory development plans
- Prescription to non-prescription switches — evaluation of candidates, program design
- Preparation for advisory committee and other regulatory meetings including background documents, rehearsals, Q&A and actual meeting attendance (FDA, EMEA,MHRA and other competent national authorities)
- Responses to regulatory communications including requests for additional data
- Evaluation of existing portfolio, program or data to assess the chance of success, and identify weaknesses or gaps in data.
- Due diligence evaluation
- Critique of documents for submission
- Development of scientific and commercial strategies for product differentiation
- Adjudication of divergent intra-company views as objective outsider
- Support for scientific litigation
- Evaluation of claims
- Organizational and Process Development
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