What We Do

Development & Quality Control of Pharmaceutical and Chemical Products

Bioassay GmbH specializes in the development, validation of bioassays and potency testing for pharmaceutical and chemical products.

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 clients to establish efficacy models to meet their new drug characterization for novel drugs and biosimilar testing.

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BioPharma Safety

We offer a variety of safety
assessment studies to support
product registration.

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Quality Assurance

Transparent and Efficient Quality Assurance

In addition to the development of custom potency assays we provide qualification and validation services of your assay under current Good Manufacturing Process (cGMP) to meet current standards for GMP product release. We also perform GMP batch release testing for clients.

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GMP, GLP Certified and FDA Approved

Quality Management

QM Ft img 1GMP, GLP and FDA certifications

QM Ft img 1In addition to regular audits by the authorities we have successfully passed audits by many of our customers to check our quality systems.

QM Ft img 1Our facility is equipped with state-of-the-art equipment and undergoes regular calibration, maintenance to ensure accuracy and reliability of results..

QM Ft img 1Quality control under GMP & GLP requirements are ensured and enforced through a QA department that oversees our quality program.

Your Development Partner

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