Enable batch release or specialized batch comparability under full cGMP with Covance to meet the European Annex 13 cGMP and other guidelines. You benefit with Covance's full range of strategies and techniques using a subset of characterization assays to release your formulated product. Covance can also provide specialized batch comparability studies.

Covance offers:

  • Data reporting flexibility for your individual needs
  • Stand-alone testing documents for information purposes
    • certificate of analyses for individual production lots
  • Single, comprehensive batch release testing documents
  • Technical and quality assurance expertise
  • Rapid turnaround, efficient management
  • Close communication with you, manufacturing groups and Qualified Persons

Batch and lot release testing on bulk harvest material

Assays are performed by Covance on a case-by-case basis for monitoring of product bulk harvest in case of a breakdown in GMP.

Biomanufacturing Support

Click here to learn more about Covance biomanufacturing support services. 

Biomolecules

Develop, characterize, test and validate with Covance, no matter what technique or molecule you're pursuing. Our experience covers a wide range of biomolecules, including: