About Us » Quality Management

Quality Policy

Quality by Design is integral to the quality systems and operations we perform for customers.

Quality Objective

To meet or exceed customer expectation through focus on quality, phase appropriate compliance, and value of deliverables.

PAC (Phase-appropriate Compliance) System

As a biopharmaceutical CDMO, GenScript ProBio business covers lifecycle phases of biopharmaceutical products, includes earlier phase of R&D (e.g. discovery), preclinical research, process development, and GMP manufacturing for clinical phase I, II and III. An GenScript ProBio special, effective and efficient PAC quality system is developed and established to meet all phases’ needs, by adopting stringent regulatory requirements of internal and international aimed markets, e.g. China-NMPA, US-FDA, EU-EMA, MHRA, ICH and WHO.

Our robust and innovated PAC Quality System will promote technical innovation, ensure our deliveries to customers are of high quality & value, and will support our customers to accelerate the development & commercialization process for new biopharmaceutical products.