Our quality system has passed numerous quality audits from big pharma companies and is in compliance with regulatory requirements. Our GMP API and drug product manufacturing facility is qualified for manufacturing GMP API and drug product to support clinical trials worldwide.

Quality assurance system follows ICH Quality Guidelines and supports API and drug product development and manufacturing in compliance with FDA, NMPA and EMA for all cGMP requirements

Regulatory support preparation for full data packages and documentation for regulatory filing

* Continuous process improvement to increase yield and reduce waste amount.

* Qualification of new vendor of key starting material to reduce supply chain risk and ensures supply sustainability.

* Systematically evaluate vendor's risk level through supply chain risk evaluation system, considering vendor's GMP, EHS level, financial situation, location etc.

* Develop next generation process of early intermediates prior to RSM by using new technology such as enzymatic catalysis, flow process, asymmetric hydrogenation etc.

* Change control management ensures the change complies with the regulatory' requirement in product whole life cycle.