Regulatory Risk and Opportunity Evaluation
COC offers private equity firms, venture capital groups and individual investors a comprehensive assessment of orphan products’ regulatory risk and opportunity. Although intertwined with scientific risk, regulatory risk can be seemingly unpredictable. However, fundamental principles and knowledge of the Agency’s “inner workings” can help mitigate regulatory uncertainty.
For new products:
Review and assessment of the sponsor current regulatory strategy
- Proposal for optimizing that strategy
- A fair assessment of regulatory risk under optimal approach
For products with prior submissions to FDA:
- Independent review of all prior regulatory communications
- Assessment of product’s current regulatory standing
- Independent, dispassionate assessment of regulatory success
- Proposal for the best strategy for the regulatory path forward
COC works on a project basis in order to remove uncertainty and ensure the client has clear expectations and guidelines for what will be accomplished. After the initial consultation, a proposal for the scope of work and the fee for completing it will be prepared and presented to a client.
Although we encourage comprehensive packages, sometimes drug developers and other are interested in one-time conversations on one or multiple drug development issues. For this type of engagement, there is a one-hour minimum; hourly rates available upon request.
