GLP/GCP BIOANALYSIS
Pharmidex provides GLP/GCP compliant analytical services for preclinical and clinical development, covering PK, TK and biomarkers.
Our team is trained for GCP, GLP and non-GLP studies, ensuring efficiency and regulatory compliance.
Bioanalysis Service
Pharmidex has a team with many years of experience in regulatory bioanalysis, including with difficult and unstable drugs and metabolites.
Areas of Expertise
- Quantitative analysis of drugs, metabolites and biomarkers in biological fluids and tissues
- Analysis using small sample volumes, to support the 3Rs (replacement, reduction, refinement) principles
- Method development and transfer capabilities for compounds in all stages of development
- Method validation to regulatory guidelines including ICH M10
