Chemical/Physical Analytics.

Our Laboratories for Chemical/Physical Analytics are providing analytical services of Drug Substances (DS)/Active Pharmaceutical Ingredients (API), Drug Products (DP)/Finished Drug Formulations (FDF), excipients and In-Process Samples for pharmaceutical industry.

The laboratories have a valid Certificate of GMP compliance as a manufacturer for Quality control testing, Chemical / Physical testing and are registered with and regularly inspected by EMA and FDA.

The FDA performed last inspection of the laboratory in 2019, and reported “no action indicated” (“NAI”) and facility was considered in an acceptable state of compliance with regards to GMP.

Core offering:

  • Chemical / physical quality control of medicinal products
  • Quality control of APIs, FDFs and excipients
  • Process quality control of medicinal products
  • Analyses of process validations, cleaning validations (analysis of swabs and rinsing liquids)
  • Analyses of samples of stability studies
  • Development of analytical procedures
  • Validation or verification of analytical procedures and method transfer
  • Other R & D activities

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