Challenge

A late stage biotech needed a clear understanding of the processes, resource needs and timelines to establish global commercial operations to launch their leading pipeline compound, a therapy for an ultra-rare immunological disease.

Solution

Our team senior pharma commercialization consultants, with experience in building commercial operations in the US, Europe and Japan, worked in close collaboration with the client to assess the necessary team sizes needed to establish and run global headquarter and country operations. This included management, market access, marketing & sales, medical affairs, finance, quality, legal/compliance and supply chain functions. For each country, we conducted a thorough legal, regulatory and tax assessment and provided a succinct budget, staffing plan and launch plan based on critical regulatory scenarios that we identified together with the client. Subsequently, we were asked by the client to support the implementation of these plans.