Whether defining your development strategy to achieve FDA buy-in, evaluating the overall appeal of your product concept, prioritizing different product opportunities, or assessing a potential investment in an existing asset, we have product strategy offerings to set you on the path to success.
Product Concept Evaluation
Starting with a proposed target product profile, we evaluate the development risks and opportunities to provide a clear view of what end goal is possible for your product.
U.S. Market Evaluation
Evaluate the value of your product opportunity through understading the patient journey, current and future competition, unmet needs and marketing requirements, market access insights, SWOT analysis and revenue opportunity sizing.
Business Case Insights
Business case support for asset development or acquisition, including program status, rationale for product development, proposed development outline, potential risks and roadblocks, and valuation.
Product Development Plan & PIND
Complete, detailed clinical and development plan, including time and cost to market analysis, FDA feedback and necessary trials and next steps. This plan will form the backbone of the Pre-IND meeting preparation and discussion.
High-level product assessment, product concept analysis and fully FDA-vetted development plan provides clearly defined path, including time and cost to market estimate.
Targeted Strategic Advice
Strategic consulting by a cross-functional team of area experts provides insights on the specific challenges your team is facing.