We provide actionable recommendations at every stage of the development process, enabling clients to make informed decisions.
We offer hands-on assistance to develop briefing and submission packages, as we lead communication with regulators and payers.
Anticipate and address challenges throughout health products life cycle
We identify and manage product-related risks, from the early definition of the target product profile through nonclinical and clinical development, registration, launch, and commercialization. We also conduct due diligence to prepare for licensing, mergers and acquisitions. We provide actionable recommendations with essential information that enable clients to make strategic decisions. We help define the roadmap to the market, complete with situation audit, milestones, and the strategy needed to drive tangible results in line with corporate objectives. We also provide insights and course correction along the way.
Communicate with Health Authorities
We maintain established relationships with local health authorities and key opinion leaders in key geographic locations, facilitate formal and informal dialogue between the industry, regulatory agencies and payers. We author and review submission packages, anticipate questions from health authorities, and provide a rationale to support our clients’ position before regulatory and health technology assessment agencies. We often act as our clients’ representative before health authorities.
Translate Quality, Safety, Efficacy and Cost-Effectiveness into Value
Health products’ value is built during development, from the earliest stages. Supportive data needs to be gathered throughout, to demonstrate Quality, Safety and Efficacy/Performance in marketing applications and Cost-Effectiveness in value dossiers for payers. Value perception also varies across a number of stakeholders – regulators, payers, patients, healthcare professionals, and investors. Articulating various stakeholder expectations and translating Quality, Safety, Efficacy and Cost-Effectiveness into Value is our main commitment to clients.