OSD Express Tech Transfer

For late-stage oral solid dose programs, timeline predictability can be as consequential as the science itself.

This fact sheet details a structured tech transfer solution designed to deliver a GMP clinical batch within 21 weeks of API receipt, covering Phase 2 and 3 programs involving immediate-release capsules or tablets, low or high potency compounds (up to Category 3A), and roller compaction manufacturing across five global sites. The approach relies on parallel workstreams and integrated regulatory expertise rather than simply accelerating individual steps. Supporting context includes data across 415 development projects, 402 unique clients, and 35 oral new molecular entity approvals spanning major global markets.

For teams evaluating CDMO partners on speed and reliability, the full fact sheet outlines what is in scope and what drives the timeline.