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Our analytical method development process involves evaluating, designing, and optimizing techniques to measure specific drug attributes like concentration, purity, and physical properties of your drug. We use a systematic and research-driven approach, incorporating tailored experimental conditions, instruments, and detection methods. Our robust methods are sensitive, specific, and reliable, ensuring consistency and compliance for your applications.
We specialize in validating analytical methods to ensure they meet predefined performance criteria. We assess critical performance parameters, including LOQ, linearity, and system suitability, ensuring compliance with the global regulatory guidelines. The validated methods we deliver are designed to generate consistent, reproducible, and actionable data you can trust.
Our advanced sample analysis capabilities transform biological matrices into data that drives informed decision. From blood and plasma to tissues and drug formulations, we specialize in precise sample analysis to determine substance presence, concentration, and characteristics. Our expertise supports pharmacokinetic (PK) and pharmacodynamic (PD) evaluations, as well as toxicology and efficacy assessments.
Trained Scientific team
Validated Methods
Sample Processing Capability
Central Bioanalytical Lab to Enhance Your Phase Trials and Complex Drug Development
With over 20 years of expertise in handling New Chemical Entities (NCEs), our team of bioscientists ensures seamless support through every phase of clinical trials. Using highly sensitive equipment capable of quantifying down to 0.1 pg/mL, we specialize in micro-dosing studies to assess minimum effective doses. Our bioanalytical lab has vast experience across different NCE molecules, with 100+ validated methods in various matrices.
Mass spectrometry is a vital tool for precise peptide and protein analysis, offering unmatched speed, sensitivity, and versatility. Our team specializes in peptide analysis, providing detailed insights into amino acid sequences and post-translational modifications such as phosphorylation and glycosylation. We have successfully worked on small peptides like liraglutide and insulin, delivering accurate and reliable results.
Our team has developed and validated bioanalytical methods to estimate the total 25 amino acids in human plasma using three distinct techniques. These validated methods have been successfully applied to evaluate the pharmacokinetics, safety, and tolerability of amino acids in healthy volunteers
Our approach to drug analysis prioritizes both innovation and the well-being of volunteers. Our scientists utilize advanced microsampling methods to provide accurate data for pharmacokinetic studies and clinical trials while minimizing the impact on volunteers. With sample volumes as small as 10-20 µL, we deliver frequent, reliable results without burdening participants.
Volumetric Absorptive Micro sampling
Capillary Micro Sampling
Touch Activated Phlebotomy (TAP) Device
Dried Blood Spot (DBS) Sampling