Establishment of regulatory responsibility system

Provide or assist you in establishing an organizational and personnel system, as well as a quality management system, for holder regulatory responsibilities.

Supplier management of APIs, excipients, and packaging materials

1)Selection, due diligence, and comprehensive evaluation of suppliers for newAPIs, excipients, and packaging materials ;
2) Supervise the stability and risk warning of the GMP quality system of existing APIs, excipients, and packaging materials suppliers, conduct daily GMP audits, and manage major changes;
3)Drug quality research and registration changes related to the addition or APIs, excipients, and packaging materials.

Contract manufacturer management

1)Selection, due diligence, and comprehensive evaluation of contract manufacturers;
2)Supervise the stability and risk warning of the GMP quality system of contract manufacturers, conduct daily GMP audits, and manage major changes;
3)Drug quality research and registration changes related to the addition or change of contract manufacturers.

Drug registration change and re registration management

1)Drug change evaluation and classification management;
2)Supplementary registration applications caused by changes and various reasons;
3)Routine drug re-registration