Based on product quality risk management, we follow NMPA, ICH, FDA and EU regulations and guidelines to establish a quality system that meets the requirements of life-cycle management of pharmaceutical products ensure regulatory compliance for product registration and declaration.
Guidelines of Quality Control
Establishing corporate image with product innovation, gaining customer satisfaction with qualified quality control.
PDCA Model
Production Management
Preventing multi-product collinear pollution and cross-contamination; avoiding confusion and error, to ensure data reliability in production systems.
Elements of quality assurance
Quality system suitable for pre-IND and clinical drug manufacturing stages.
Quality system documentation