OSD Express IND

For sponsors under pressure to reach Phase 1 without sacrificing quality or budget discipline, the gap between API availability and GMP clinical batch release is often where timelines unravel.

This brochure outlines an oral solid dose development solution built to close that gap, with a 25-week timeline from API receipt to clinical trial material release as its central commitment. The scope covers immediate-release capsules and tablets, low and high potency compounds up to Category 3A, roller compaction, and batch sizes up to 5 kg, all manufactured at a single U.S. site. Parallel workstreams, competitive pricing structures, and a regulatory track record that includes 35 oral new molecular entity approvals provide the infrastructure behind the timeline claim.

Explore the full scope and capabilities in the brochure below.