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.
We develop and execute potency assays for biologics, proteins and active pharmaceutical ingredients under established quality guidelines.
We work with clients to establish efficacy models to meet their new drug characterization for novel drugs and biosimilar testing.
We offer a variety of safety
assessment studies to support
product registration.
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.
GMP, GLP and FDA certifications
In addition to regular audits by the authorities we have successfully passed audits by many of our customers to check our quality systems.
Our facility is equipped with state-of-the-art equipment and undergoes regular calibration, maintenance to ensure accuracy and reliability of results..
Quality control under GMP & GLP requirements are ensured and enforced through a QA department that oversees our quality program.
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