04.13.23 -- Strategic Procurement For Emerging Pharmas & Biotechs

Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

The long-awaited revision to ICH’s harmonized tripartite guidance on quality risk management (QRM), Q9(R1), was adopted on January 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.