SmartBio Analytics provides GLP-compliant bioanalytical method validation services for pharmaceutical, biotechnology and research organisations. Our team validates analytical methods according to international regulatory guidelines, ensuring accurate, reliable and regulatory-ready data for preclinical and clinical studies.
Whether you need method development, GLP validation, sample analysis, biomarker quantification, or access to our advanced instrumentation, our team delivers robust, reliable data that accelerates decision-making and ensures compliance with international regulatory standards.
Our validations include all parameters required by ICH M10, ensuring regulatory acceptance worldwide:
Demonstrating the method’s ability to distinguish analytes from endogenous and exogenous components in the matrix.
Ensuring no interference from high-concentration samples to subsequent analyses.
Establishing the lowest concentration accurately and precisely measurable.
Assessing linearity, accuracy, and precision across the analytical range.
Within-run and between-run reproducibility.
Evaluation and mitigation of ion suppression/enhancement.
Quantifying the efficiency of analyte extraction.
Verifying performance when samples require dilution.
Assessing analyte stability under various conditions (freeze-thaw, bench-top, long-term).
Full GLP validation in 4–6 weeks without compromising data quality
Validations designed for acceptance by FDA, EMA, and other major authorities
See our Non-Proprietary Assays page for a list of validated methods already available
State-of-the-art LC/MS platforms to meet the most demanding sensitivity requirements
Decades of combined experience in regulated bioanalysis — meet them on our Team page
Backed by our robust QA & Certifications, ensuring compliance and traceability at every step
With SmartBio Analytics, method validation becomes a seamless process — fast, compliant, and reliable — ensuring your bioanalytical data meets the highest regulatory standards worldwide.
