You need toxicology testing that’s accurate, compliant, and rapid. Whether you’re evaluating mutagenic potential or seeking in vitro alternatives, you must meet global regulatory standards, protect patient safety, and deliver results fast. You need expert support in designing the most appropriate testing strategy.

Eurofins BioPharma Product Testing network of laboratories provides a comprehensive range of genetic and alternative toxicology models to assess both the safety and pharmacological efficacy of a drug. With over 30 years of experience and access to state-of-the-art technology, our experts offer custom solutions and end-to-end support to ensure your products comply with the current international guidelines (e.g. ICH, US-FDA, ISO, EMEA, OECD) and the testing is performed in accordance with GLP (Good Laboratory Practice) for worldwide acceptance. We provide full nonclinical development programmes to support IMPD/IND submissions and later-stage regulatory filings for both new chemical entities (NCEs) and new biological entities (NBEs). Within our portfolio, we have several validated in vitro methods as alternatives to in vivo testing for evaluating eye irritancy, local tolerance and performance testing.

Genetic toxicology testing

Our certified teams bring deep expertise in testing pharmaceuticals, chemicals, agrochemicals, mixtures, and medical devices. We assess the mutagenic potential of your product using both in vitro and in vivo methodologies. We support you with scientific rigour and regulatory precision, delivering fully GLP-compliant studies that meet international guidelines, including ICH, US-FDA, ISO, EMEA, and OECD.

Our laboratories are equipped to design, perform, and validate in vitro assays that align with the most current scientific and regulatory expectations. We understand that no two products or development programmes are the same. Our familiarity with a wide range of in vitro systems allows us to select the most appropriate assays to address specific safety and efficacy questions. Beyond standard testing, we offer consultative support tailored to your project’s scientific and regulatory requirements. For programmes that require speed and flexibility, we offer priority testing options with accelerated turnaround.

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Alternative toxicology testing

If you're transitioning away from in-vivo testing, we can support your move to in vitro models and alternative approaches. We promote the 3Rs—Replacement, Reduction, and Refinement—as a core aspect of our approach to safety testing. Our services address the needs of both efficacy and safety, ensuring your product is safe for consumer use and does not cause any irritations, allergies or toxic side effects. We help clients navigate complex regulatory frameworks, and ensure results are robust, reproducible, and recognised by authorities worldwide.

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