Pharmaceutical Insights · Steven Li
Long-form perspectives by Steven Li on international pharmaceutical partnerships, technology transfer and cross-border quality systems.
Southeast Asia is geographically close to Hainan, but proximity alone does not create a durable pharmaceutical business. Sustainable cooperation requires national-market discipline, a clear allocation of regulatory and quality responsibilities, and stage-gated decisions from non-confidential screening through launch and lifecycle management.
Read full article →Technology transfer is a controlled product-lifecycle process, not a document handoff. A receiving site must be able to reproduce the product, process or analytical procedure against predefined specifications, with risks, responsibilities and acceptance criteria documented in advance.
Read full article →Cross-border CMO and CDMO programs need more than audits and certificates. They require a working quality-governance system that connects responsibilities, technical controls, data integrity, change management and escalation across organizations and jurisdictions.
Read full article →CMO · CDMO · Technology Transfer