REGULATORY BIOANALYSIS

Our Regulatory Bioanalysis service provides GLP/GCP compliant analytical services for preclinical and clinical development, covering PK, TK and biomarkers. 

Areas of Expertise

Highly skilled staff with many years of industry experience in regulatory bioanalysis, including with difficult and unstable drugs and metabolites, working from modern MHRA accredited laboratories with state-of-the-art UHPLC and LC-MS/MS instrumentation.


Our team ensures confidence in data generated through compliance with the appropriate GLP and GCP regulations and ICH M10 guidance. 

Key Services

  • Method development, transfer and validation capabilities for novel and established compounds
  • Overcoming challenges such as stability issues, matrix effects and the determination of multiple metabolites
  • Quantitative analysis of drugs, metabolites and biomarkers from a range of matrices (plasma, serum, blood, CSF, urine, etc)
  • Analysis using small sample volumes, to support the 3Rs (replacement, reduction, refinement)
  • Flexible support according to client requirements, whether large institutions or small start-ups
  • SEND Formatting
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