Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Quality control

In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

Laboratory
Development and validation

Development and validation

Identity testing, assay, purity testing and in vitro dissolution

Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Development reports, validation plans and validation reports can be prepared in English, German or French and integrated directly in your marketing-authorisation dossier.

Identity testing and assay

Chromatography methods (HPLC/UPLC/GC/TLC) with a wide range of detection methods
LC-MS, GC-MS
Electrophoresis with different detection methods
Spectroscopic methods
Titrimetric methods

Purity testing

Stability-indicating testing for impurities of active ingredients and finished products incl. peak-purity evaluation
Forced degradation studies to evaluate degradation paths and mechanisms
Differentiation between degradation products and synthesis by-products