Our Service Offering

Bioanalytical contract research services to support your pipeline from discovery to approved product release testing.

Bioassay GmbH specializes in the development and validation of robust bioassays to evaluate potency and bioactivity of your compound.

Our services are performed under GMP and GLP certification to meet regulatory guidance for pre-market and on-market products.

BioPharma Potency

We develop and execute potency assays for biologics, proteins, and active pharmaceutical ingredients under established quality guidelines.

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BioPharma Efficacy

We work with you to establish efficacy models to test your new drug or biosimilar.

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BioPharma Safety

A variety of safety assessment studies to support your product registration.

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GLP Offering

We support your compound selection before registration with complementary in vitro/in vivo acute toxicity and skin sensitization services.

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Experienced team, customizable assays, and no waiting lists

Bioanalytical assays are our core expertise. When you work with us you gain immediate access to our team of experts with focus and flexibility without long waiting lists.

Our Services

Quality Assurance

Transparent and Efficient Quality System

Every aspect of our operations is governed by a robust quality system designed to meet regulatory requirements and maintain data integrity. We continuously improve our processes to deliver exceptional services and testing results you can rely on.

Our assay qualification and validation services are performed under current Good Manufacturing Process (cGMP) to meet current standards for GMP product release. Additionally, we perform GMP batch testing to support your post-market release.

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Advanced Analytical Equipment

2000 m2 state-of-the-art facilities

Our in vitro and in vivo laboratories at Heidelberg Technology Park are equipped with state-of-the-art instruments to ensure the highest precision and efficiency in our assays and execute studies under highly controlled regimes.

Bioassay’s analytical teams can develop and validate new in vitro potency assays accordingly to ICH-Guidelines, can optimize existing assay formats and transfer data into routine applications for a wide range of active pharmaceutical ingredients (APIs) and drug products.