Sinopep is fully committed to providing the highest quality products and services. The Sinopep "Quality Manual" is established based not only on the requirements of regulatory agencies such as NMPA, US FDA, EMA, ICH, and regulatory guidelines such as 21 CFR Part 210/211/820 and ICH Q7/Q8/Q9/Q10, but also on Sinopep's top management's strong commitment to ensuring our operation and control of processes in CMC (Chemistry, Manufacturing and Controls) are conducted in full compliance meeting the highest level of global quality requirements.

Sinopep’s Quality System spans the entire product lifecycle, encompassing all phases of clinical development, commercial launch, and post-launch activities.

• Quality System
• Laboratory Control System
• Material Management System
• Production Management
• Facility & Equipment Management
• Packaging & Labeling System

These elements are effectively implemented across all stages of the product lifecycle, with consideration given to the specific objectives and requirements of each phase. Opportunities for quality improvement and efficiency enhancement through innovative solutions are carefully assessed and introduced at appropriate timepoints, ensuring full regulatory compliance.