We have delivered 20+ EU-GMP/WHO-GMP compliant facilities. Our expertise spans solid-dose (OSD), liquid, and sterile manufacturing, featuring advanced pressure cascades, strict aseptic zoning (Grade A/B/C/D), high-OEB containment for oncology, and precise temperature controls for bioprocessing and viral vectors.
Compliance is engineered in, not bolted on. Operating under GAMP 5, we deliver complete DQ / IQ / OQ / PQ validation packages with full traceability, plus SCADA / EBR validation to 21 CFR Part 11 and EU-GMP Annex 11 — backed by a track record of zero major findings on first qualification audits.
