Supply Chain Sustainability: Manufacturing Of Regulatory Starting Materials (RSMs) And Key Starting Materials (KSMs)

By Ganesh Venkatraman, LAXAI

Supply chain and shipping disruptions are a major concern at all stages of drug development and include, but are not limited to, geopolitical strife, regulatory entanglements, and limited product availability. While these challenges are impactful throughout drug development, their influence is perhaps most keenly felt in the form of long lead times and other delays when attempting to acquire regulatory starting materials (RSMs) and key starting materials (KSMs) for new chemical entities (NCEs).

De-risking RSM and KSM procurement can be accomplished via several means, but local sourcing of raw materials and, if necessary, in-house production, have proven tremendously effective. Ensuring a stable and economical supply chain requires more than having a few trusted suppliers. It means having contingency plans for your contingency plans, as well as the expertise to deliver on those plans at a moment’s notice. LAXAI evaluates each project individually, and we work closely with clients and other partners to “think outside the box” by developing ways to ensure sustainability.