GCP Bioanalysis Services
Good Clinical Practice (GCP) compliant bioanalytical laboratory services (UK) supporting human clinical trials in compliance with UK and EU legislation
Intertek's GCP bioanalysis services strive to ensure that Good Clinical Practice (GCP) compliant bioanalytical methods are applied to the analysis of study samples for human clinical trials, as described in the European Medicines Agency (EMA) 2012 Guidance.
GCP is a set of internationally recognized, ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects (EU Directive 2001/20/EC, article 1, clause 2). A bioanalytical CRO would require an understanding of the applicable GCPs in order to identify the impact of deviations from a clinical (non-GLP) bioanalytical study or clinical protocol.
Our GCP compliant bioanalytical laboratory conducts human clinical trial sample bioanalysis following the principles of GCP and our staff are fully trained on the GCP expectations associated with clinical sample integrity, respective data integrity and communications, patient safety and confidentially requirements. Our bioanalysis laboratories offer both GCP and Good Laboratory Practice (GLP) bioanalysis contract services to support preclinical and clinical development for a range of product types including small molecule pharmaceuticals, proteins and PEGylated products. GCP bioanalysis services are available across a wide range of bioanalytical technologies, and delivered via our team of experienced Regulatory Project Managers.
Intertek also holds a Human Tissue Licence, regulated and inspected by the Human Tissue Authority (HTA) in the UK, facilitating analytical studies to support our client’s clinical research programs.
- Bioanalytical Technologies
- Bioanalytical method development and validation
- Clinical sample analysis (Human Plasma and Urine)
- Pharmacokinetic (PK) and pharmacodynamic (PD) bioanalysis for small molecules and biologics
- Metals and Inorganic Bioanalysis
- PEGylated drug bioanalysis by NMR
- Non-Standard Bioanalysis Methods
- Stability testing in dose formulations
- GCP Auditing of sub-contractors or suppliers
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA
Bioanalysis Services Brochure
Trace Metals Bioanalysis and Biomarker Quantification
White Paper Downloads:
Biomarker Development and Validation
Bioanalysis Of Pegylated Species In Human Plasma By NMR