Does Your CDMO Have Sustainable API And RSM Strategies?

By Scott Martin, Grace FCMS

A wide range of factors are reshaping today’s pharmaceutical supply chains. This includes, but is not limited to, a growing pipeline of diverse small molecule products, emerging markets that continue to reshape the industry landscape, and increasing regulatory expectations. Now the world is facing COVID-19, which is driving many pharmaceutical companies to reexamine their supply chain strategies and footprints. Despite these challenges, it is the responsibility of the pharmaceutical innovator to make sure they establish a reliable supply chain that is compliant with global regulatory expectations. A critical part of doing so is having regulatory starting material (RSM) and active pharmaceutical ingredient (API) strategies that ensure continuity of supply throughout the life cycle of a product.

However, if you are working with a CDMO for the development and manufacture of your product, you are reliant on their supply chain. How can you be sure the one you select has appropriate oversight and management of their RSM and API manufacturing supply chain, so you do not experience costly delays that disrupt your timeline and prevent your product from reaching the patients who need it?