
GMP OEM / Contract Manufacturing
From small to commercial batches, including batch records, release testing, and complete turnover packages.
From feasibility to commercial supply—one partner across equipment, process, and quality.

From small to commercial batches, including batch records, release testing, and complete turnover packages.

DoE design and parameter mapping from lab coater to commercial lines, with reproducibility and data tracking.

Commissioning, operator training, SOP/cleaning documentation, and FAT/SAT support.

Risk assessments, protocols, execution, and reports aligned to cGMP expectations and audits.