CMC and QA

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CMC

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.
 

 

 

QA

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
  •   

 

 

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