Building Pharma with Precision. End-to-end commissioning, qualification and validation for the facilities that manufacture medicine.
Better yet, see us in person — we welcome clients in the pharma industry during normal business hours to discuss CTOP, GMP and validation practices.
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From clean utilities to turnover packages — disciplined commissioning, qualification and validation delivered to GMP standards.
End-to-end commissioning and qualification of new pharma manufacturing facilities, from utilities to OSD production lines.
IQ/OQ protocol review and execution for bioreactors, autoclaves, isolators, freeze dryers, and centrifuges.
Commissioning of WFI, Purified Water, Clean Steam, HVAC, Compressed Air, and Chilled Water systems.
Contractor coordination, scheduling, HSE supervision, and progress tracking on pharma construction projects.
CTOP, VTOP, and TOS documentation review, walkdowns, and Mechanical Completion package coordination.
Supplier audits, incoming material QC, and piping documentation review (WPS, WPQR, pressure tests, orbital welding).
Two decades of pharmaceutical validation and construction management delivered for the industry's leading manufacturers.
C&Q Lead for new oral solid dosage (OSD) manufacturing facilities in Switzerland.
20+ years of pharmaceutical validation and construction management under GMP, FDA, and AIFA standards.
Clean utilities specialist: WFI, Purified Water, Clean Steam, HVAC, and Compressed Air commissioning.
CTOP and VTOP documentation review, walkdowns, and turnover package management.
Project delivery for Bristol Myers Squibb, GSK, Bayer, Biogen, CSL Behring, and Thermo Fisher Scientific.
IQ/OQ qualification of bioreactors, isolators, autoclaves, freeze dryers, and cleanroom HVAC systems.