Quality & Compliance
Quality & Compliance
AsymBio Quality Policy
Providing a quality control and operation system that complies with global regulatory standards. Our quality system meets the regulatory requirements of NMPA, FDA and EMA
Adhering to Stringent Quality Standards, Cultivating a Rigorous Quality Mindset

Establishing a biologics platform-based high quality management system for continuously improving products, services, and the quality system based on Asymchem Group’s past success with small-molecule drugs and the macromolecular characteristics of biologics

Satisfying clients’ requirements at different stages of innovative biopharmaceutical development (including antibodies and recombinant biotherapeutics, bioconjugates, plasmids, mRNAs, etc.)

Ensuring that quality management covers all stages of the product lifecycle, so as to ensure the safety, quality, and efficacy of our clients’ drug products

Good Audit Records

Since 2019, AsymBio has frequently invited third-party professional institutions, former regulatory inspectors, and industry experts from both China and other countries to perform mock audits so as to continuously improve the quality management system

Since 2021, AsymBio has successfully passed approximately 20+ cGMP audits from our customers