Companies in this sector face enhanced regulatory and oversight challenges, compliance expectations, and sometimes significant global supply chain issues related to critical ingredients or components. They contractually sponsor vast amounts of research at research universities globally. Strategic risks threaten their traditionally high profit model – the expiration of core patents, favorable policy treatment of generics manufacturers, sovereign-supported counterfeiting challenges in developing countries, and intense pricing pressure from government healthcare spending policies and managed care providers.
The importance of operational continuity in this sector is paramount. Disruptions in R&D, manufacturing, supply chain and distribution can impact financial results quickly, and invite enhanced scrutiny by regulators.
Services and Solutions
Risk Solutions International has completed business continuity and supply chain continuity engagements at companies ranging from Fortune 500 pharmaceuticals, leading genome sciences developers, and a manufacturer of skin grafting devices to a tissue transplant organization and a manufacturer of health screening and assessment devices. We have advised companies that develop substances that are part of the Strategic National Stockpile on mitigating operational risk. We do business continuity work for leading research universities that do sponsored research for leading pharmaceutical and life sciences companies, and that must plan for the continuity of high value research assets in their operational risk strategies.