Know, what´s inside:
GBA Preclinical Services

Toxicology, Metabolism & Analytical Services for Drug Development

Expert Guidance and Testing for MedTech Success

Since 1994, the GBA Group has been supporting manufacturers in the development, approval and production of safe medical devices. At GBA Group, we are committed to advancing the MedTech industry through comprehensive solutions, expert advice and precise testing. We combine consulting and laboratory testing in a unique way, supported by our experts throughout the entire life cycle of medical devices. Our specialist departments work hand in hand to provide medical device manufacturers with unparalleled support throughout the product lifecycle: from concept and development to approval and production monitoring.

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KaLy-Cell supports manufacturers in developing, approving, and producing safe medical products through:

Biological and Chemical Testing Manufacturing, Cleanliness and Sterilization, Validation, Packaging Validation (Repeated), Processing Validation, Biocompatibility Testing

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ICCR-Roßdorf GmbH is a leading contract research organization with more than three decades of toxicological experience. We offer our customers services in the fields of pharmaceuticals, chemicals, agrochemicals, cosmetics and medical devices.

Regulatory testing for mutagenicity, genotoxicity and cytotoxicity is just one focus of our activities. We are equally specialized in in vitro methods in the field of sensitisation as well as irritation and corrosion on skin and eye models. For testing the biocompatibility of medical devices, we have many years of experience in the testing of extracts in accordance with ISO 10993-1. In addition, batch release tests of pharmaceuticals under the GMP quality standard complete our portfolio.

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Pharmacelsus, Germany´s market-leading early stage CRO, plans, organizes and realizes customized preclinical studies for more than 20 years. The Pharmacelsus portfolio covers the complete drug discovery and development testing program for small molecules and peptides in vitro, in vivo, ex vivo as well as G(C)LP and non-GLP bioanalysis. Structural, physicochemical and functional characterization of Biopharmaceuticals (e.g. Antibodies, ADCs, etc.) complements our comprehensive portfolio.

Contact us

Do you want to qualify your product efficiently and safely?

BD@pharmacelsus.de

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