Portfolio
De GMP en GDP projecten waar we het meest trots op zijn.
WHO GMP Upgrade
After an unsuccessful WHO inspection, Panacea Biotech sought assistance from PCS to enhance...
GDP QMS Implementation & Achieving WDA
PCS implemented a GDP QMS for a British manufacturer with a Dutch subsidiary, aiding in...
U.S. FDA Inspection Preparation
PCS developed an extensive US FDA inspection preparation program for a Dutch biotechnology...
WHO Implementation for Prequalification
In collaboration with Bharat, PCS enhanced the Pharmaceutical Quality System (PQS) and...
FDA Inspection Readiness & Mock-Inspection
PCS conducted an extensive consultancy assignment for Solvay Pharmaceuticals in Germany,...
WHO GMP Assessment of Zimbabwean Pharma Industry
PCS was tasked by UNIDO to audit the Zimbabwean pharmaceutical industry based on 17 key...
GMP Quick Scan & PIC/S Training in Pakistan
PCS performed a quick scan of a number of Pakistani pharmaceutical companies against international...
GMP for a Medical Gas Manufacturing Facility
PCS supports a Dutch manufacturer of medical gasses in achieving a Manufacturing and Import...
GMP Implementation for a Manufacturer of Mosquito Repelling Products
PCS is assisting a European manufacturer of mosquito-repelling products in attaining GMP...
WHO GMP PQ Support
Performing a WHO GMP gap assessment at Sinovac China to prepare Sinovac for WHO prequalification...
WHO GMP Gap-Assessment & Upgrade Support
PCS conducted a comprehensive nine-day WHO GMP gap assessment at Yuxi Walvax Biotechnology...
U.S. FDA GMP Implementation for a Manufacturer of a Novel Protein Platform
PCS has helped a U.S.-based manufacturer of a novel protein platform with full GMP implementation...
FDA Pre-Approval Inspection
For Wyeth Lederle Vaccines and Pediatrics (U.S.), prior to their takeover, PCS performed...
Development of top-level Quality System SOP's for GMP-compliant product development
PCS performed a review of the current quality system's SOP's on GMP-compliant product...
Audit and Computerized Systems Validation (CSV) Support
PCS performed a five-day GMP audit of Zentiva a.s. Hlohovec and Zentiva a.s. Prague, to...