CMC and QA

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    2Y-Chem, Ltd.
  • Add: No.10, Lane 1000, Zhangheng Road, China (Shanghai) Pilot Free Trade Zone
  • Tel: 86-21-51320090
  • Email:
  • Web:

    2Y-Biopharma, Ltd.
  • Add: Jiangfeng Road, High-Technology Industrial Development Zone, Qidong, Nantong, Jiangsu, China
  • Tel: 86-0513-83266672-8001
  • Fax: 86-0513-83266672-8005


Our dedicated and talented staff has a solid track record supporting the regulatory filings in Chemistry, Manufacturing and Control (CMC) for use in IND/IMPD/ANDA. 

Based on excellent records, and entrusted by customers worldwide, 2Y-Chem has contributed to the development and manufacturing of a number of new chemical entity (NCE) APIs for clinical trials in EU and in the USA.




2Y-Chem’s QA leads the organization in quality management, and plays a supervisory
and auditing role for all quality systems.

Areas covered by our QA include but not limit to

  • ·Raw material release
  • ·Batch record review
  • ·Intermediates release
  • ·Final product release
  • ·Change control
  • ·Deviation/OOS investigation
  • ·Document retention and archives 
  • ·Regulatory files preparation