§ 02.3 cGxP
cGxP
Validation, process optimization, and GLP testing across pre-clinical through early commercial — for peptides, biologics, devices, and combination products.
Current Good Practice (cGxP) work spans the full lifecycle: validation protocols, process optimization, GLP testing, and release. We work across modalities — small molecules, biologics, peptides, medical devices, combination products, IVDs, and cellular and tissue products — bringing pragmatic, inspection-ready discipline to operations that need to move fast without compromising compliance.
§ 02.3.A What we deliver
Specific engagements in cGxP.
- 01 Pre-Clinical / Clinical / Early Commercial
- 02 Validation IQ / OQ / PQ
- 03 Process Flow / Optimization
- 04 QC GLP Test and Release
- 05 Peptides / Small Molecules / Biologics
- 06 Medical Devices / Combination Products / In Vitro Diagnostics (IVDs)
- 07 Cellular and Tissue products (HCT/P)