FROM DISCOVERY TO APPROVED TREATMENT

Bridging innovation with regulatory frameworks

We conduct qPCR and dPCR assays in accordance with GLP accreditation, GCLP compliance, and ISO/IEC 17025 standards.

Cell and gene therapy experts

GLP and GCLP simplify data auditing

We provide comprehensive support for drug development across all phases, holding GLP accreditation for preclinical sample analysis and complying with GCLP standards for clinical sample analysis. Accredited by SWEDAC, we adhere to rigorous requirements for qPCR and dPCR through regular external audits, ensuring our analyses’ reliability, integrity, and reproducibility, which are mandated for regulatory filings.

Our regulated services include bioanalysis assays such as PK/PD, shedding, biodistribution, and transgene expression for cell, gene, and RNA therapeutics.

GLP and GCLP

We hold GLP accreditation for qPCR and dPCR services and adhere to the GCLP guidelines, necessary for regulatory filings of pre-clinical and clinical analysis data, respectively.

ISO/IEC 17025

We are accredited for ISO/IEC 17025 for both sample preparation and downstream qPCR analysis, ensuring technical competence, reliability, and valid results.

compliant bioanalysis

Accurate and reproducible data

A GLP accredited and GCLP compliant laboratory

TATAA Biocenter is accredited by the Swedish Board of Accreditation and Conformity Assessment (SWEDAC) for complying with Good Laboratory Practice (GLP) standards. We also adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which are international quality standards governing the analysis of samples from clinical trials using GLP.

GLP and GCLP ensure the reliability, consistency, and validity of data from non-clinical and clinical studies, respectively. These standards cover every aspect of study planning, execution, monitoring, documentation, archiving, and reporting. This rigorous process provides assurance to both the sponsors when submitting data for new drug approvals, and the regulatory authorities when reviewing the data, that it is generated in a regulated manner.

drug development TATAA Biocenter
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method validation

Accelerate drug development with validated assays

Validated bioanalyses are essential throughout the entire drug development process

In the initial stages of discovery, it’s acceptable to conduct fit-for- purpose validations. These validations offer valuable insights into the expected range of analyte performance before undertaking the comprehensive GLP-validation process. When it comes to preclinical and clinical assays, GLP-validation or GCLP validation is mandatory to demonstrate accuracy, reliability, and consistency. Our fully validated assays offer dependable data for making stage-gate decisions and preparing regulatory filings.

A validated assay is a valuable asset.

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PK/PD​ bioanalysis

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