PQE Group

PQE Group is a global, privately-held service provider focused on quality, compliance, and digitalization for the life sciences industry. With over 25 years of experience, 40+ offices worldwide, and a portfolio of 15,000+ projects, it serves as a strategic partner for pharma, biotech, and medical device companies navigating complex regulatory environments. The company differentiates itself through its women-owned leadership, ISO 9001-certified processes, and a comprehensive service suite that includes clinical research (CRO) services via its ReSQ-UP offering, automation, and sustainability consulting. Its business model is purely service-based, generating revenue through consulting fees and project-based contracts.

Integrated service methodology combining deep regulatory expertise, a global talent network, and digitalization services for GxP compliance, including automation strategy, system implementation, and clinical trial digital tools (eTMF, EDC).

PQE Group competes with large, global Contract Research Organizations (CROs) like IQVIA and Parexel, broad-based consulting firms, and smaller niche compliance consultancies. Its differentiation lies in its women-owned status, integrated quality/compliance/digitalization offering, and focused expertise across the medical device and pharma sectors.