PSC BIOTECH LIMITED

PSC Biotech Limited is a Dublin-based life-science consulting partner that helps organisations navigate the complex world of regulatory compliance, quality assurance and engineering. Drawing on a team that includes former FDA auditors and seasoned industry specialists, the company delivers practical, risk-focused solutions to clients ranging from start-ups to multinational manufacturers.

Their service portfolio covers the full spectrum of life-science support. PSC Biotech offers commissioning, qualification and validation (CQV) for facilities, equipment and processes, as well as computer-system validation (CSV) and data-integrity assessments for enterprise applications such as QMS, ERP, LIMS and MES. The firm also provides audit services (supplier, gap analysis, GLP/GMP, data integrity), ISO-certified metrology, quality-assurance guidance, regulatory advice (FDA, EU, EPA, OSHA, USDA) and technical documentation including FDA responses, protocols and specifications. Project management, engineering design and equipment selection round out their end-to-end offering.

With a presence in more than 30 countries across the Americas, Europe, Asia-Pacific and the Middle East, PSC Biotech combines global expertise with local insight, enabling clients to launch new products, scale operations and maintain compliance with confidence. Their collaborative approach is consistently praised by leading pharmaceutical and medical-device companies for delivering timely, cost-effective results.