GMP Services

Only the Best for Your Molecule

Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, ANVISA, etc.

We have over 40 highly qualified and motivated professionals (more than half of which have university degrees) ready to identify and apply the best solutions for your project. You can also count on a whole battery of GMP-compliant quality control measures:

  • Method transfer or implementation
  • Validation of analytical procedures according to ICH and USP
  • Lifecycle management of your methods
  • Adaption of platform-based methods to your product
  • Verification of compendial procedures
  • In-process and release testing of intermediates, drug substances and drug products
  • Comparability testing
  • ICH conform stability testing
  • Testing of raw materials and facility supply (e.g. water, clean steam, WFI)
  • Characterization of cell banks

All documentation conforms to eCTD and can be directly used for your application.

“The FDA approval paves the way for Richter-Helm BioLogics to serve the global market.”

(customer)