Quality Regulatory
Fully integrated CMC services boasts a proven track record of over 100 clients. With over 20 IND & Generic DMF Filings, our team has deep experience in complex Sugar Chemistry & heterocyclic compound manufacturing.
Quality Systems
- Quality Management
- FDA cGMP compliant quality system to ensure the quality of its services and products.
- Employees are trained and qualified in all aspects (operational, safety, data integrity, confidentiality, etc.) prior to working independently on our clients’ projects.
- 100s of SOPs were established to ensure the quality of service from raw materials to final products, from laboratory to pilot plant, and from operator to chief executive officer.
- 100s of audits passed from global pharmaceutical companies and health authorities around the world
- Quality Assurance
- SOPS, training management
- Good documentation practice
- Archive management
- Material & specification management, vendor qualification and contract manufacturer qualification, calibration and maintenance, quality incident management, including deviation, OOS, customer complaint, and product recall as well as change control , validation and qualification management, package and label management, internal audit and routine inspection
- At our Taicang plant, we are ICH Q7 compliant and have four level documentation framework, batch record reviews, change control and deviation investigation, CoA review and approval, robust training program and over 200 QA related SOPs in place
- EHS Management
- EHS Policy
- Strictly complies with all applicable national and local EHS laws, regulations and standards
- Suitable internal SOPs are well established and implemented for EHS controls
- EHS Accountability
- EHS Department is responsible for providing guidance, robust training for all of hazardous reactions, field safety, regular safety assessment report and other safety related issue
- Sustainability
- Strictly control the discharged quantity of waste, improve the wastes treatment ability to minimize the environmental impact