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Quality Assurance (QA)

aCROnordic's corporate QA function is designed and applied to ensure compliance with the standards of ICH/FCP, FDA, EMEA and OECD.

The unit offers the following services externally:

  • GCP training
  • GCP audit:  
    - Sponsor audit  
    - Investigator site audit  
    - Clinical trials report audit 
    - System audit
  • GMP audit:
    - Manufacturing/distribution site audit              
  • Planning, documentation, and implementation of QA systems
  • Support in the selection of contract manufacturers
  • Certification of batches by a qualified person (QP)