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A Marketing Authorization Application (MAA) for a new pharmaceutical must contain all preclinical data available on the product specification and quality, bioavailability and metabolism, toxicology and safety pharmacology as well as efficacy and pharmacodynamics. This information must be provided to the regulatory authorities before initiation of clinical testing in humans.
We perform studies required for the approval of your drug with the regulatory authorities as well as studies on your chemical for its registration with the European Chemicals Agency ECHA for the REACH program. We´ll also test your food additive according to the European Food Safety Authority EFSA.
Our services include:
- Cell-based and humoral immune response
- Studies on vaccines
- Potency/efficacy testing
- Pharmacokinetics / Pharmacodynamics
- Tumorigenicity / Oncogenicity studies
- Determination of anti-drug antibodies (ADA)
- Biosimilarity / Biocomparability / Bioequivalence
Toxicity testing [GLP]
Medical devices testing [GLP]
Adventitious viral agents testing [GMP]
- Tests of cell substrates and cell-lines on adventitious viruses (in some guidelines referred to as „viral safety“)
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