Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, ANVISA and other regulatory bodies
We have over 90 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 and validation
Validation of analytical procedures according to ICH and USP
Lifecycle management of your methods
Platform-based methods that can be adapted to your product
Verification of compendial procedures
In-process and release testing of 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”