Regulators and payers are two of the most important external stakeholders affecting health products development. To address both, supportive data needs to be collected throughout development and commercialization – to demonstrate Quality, Safety, Efficacy/Performance and Cost-Effectiveness. Coordinating data collection and value demonstration, jointly fulfilling regulators’ and payers’ requirements enables manufacturers to accelerate product development, and avoid unnecessary additional costs through the duplication of research studies.
From strategy through implementation
We do not only provide strategic recommendations and leave clients with responsibility for implementation. We do not just prepare submission packages either. We provide strategic recommendations, and then roll up our sleeves to guide and work with our client’s project teams on implementation – hands-on. Over 75% of our new assignments are with existing clients, as we help expedite product development and optimize commercialization in long-term collaborations.
Global strategies, interaction with local regulators and payers
With a presence in North America, Europe and Southeast Asia, we design global strategies and adapt execution in each market – accounting for local medical practices, regulatory frameworks and reimbursement landscapes. We have been interacting for more than two decades with regulators, payers and key opinion leaders in these markets. The privileged relationships that we have developed facilitate formal and informal dialogue between the industry and health authorities.
Integrated expertise and industry experience
Along the product timeline, an integrated set of product- and market-specific expertise enables our team to address complex problems and anticipate future challenges. Our successful track record in helping manufacturers (and investors) successfully commercialize their products, proves that a robust regulatory and market access framework is critical in today’s healthcare environment.