Analytical Methods

Bioanalytical method development and validation

At Vivotecnia we offer full bioanalytical method development and validation services to support nonclinical and early-phase clinical studies. Our goal is to ensure that drug concentrations and biomarkers are measured with high sensitivity, accuracy and reproducibility – meeting international regulatory requirements and enabling informed decisions at every stage of development.

Established — 2000

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Our team works with a wide range of matrices and compounds types, from small molecules to biologics, including highly complex formulations. All methods are developed and validated according to EMA and FDA bioanalytical guidelines and under full GLP compliance.

Precision bioanalaysis for reliable exposure data

We develop quantitative and qualitative methods tailored to the physicochemical properties of each analyte and its biological matrix. Once established, each method undergoes validation to demonstrate accuracy, precision, selectivity, reproducibility and stability under the intended conditions of use. Our bioanalytical services support toxicokinetic (TK), pharmacokinetic (TK), and exposure assessments required for regulatory toxicology studies and decision-making processes in preclinical development.

What we offer at Vivotecnia

Development and full validation of quantitative methods in plasma, serum, urine, tissues and other biological matrices

Expertise in LC-MS/MS, UPLC and HPLC platforms for small molecules, peptides and biologics

Validation of critical parameters: accuracy, precision, selectivity, carry-over, dilution integrity and stability

GLP-compliant documentation and reporting, aligned with EMA/FDA guidelines

Industries we support

Pharmaceutical

Biotechnology

Chemical

Advanced Therapies Medicial Products (ATMPs)

Infrastructure and equipment

Our bioanalytical laboratories are equipped with cutting-edege instrumentation, including SCIEX Triple Quad LC-MS/MS systems, UPLC, HPLC and robotic automation platforms for high-throughput sample processing. Sample handling, data capture and reporting are managed through fully validated digital systems (e.g., Provantis and 21 CFR Part 11-compliant platforms), ensuring traceability and integrity.

WHY VIVOTECNIA

Wide bioanalytical scope

Valiated methods for small molecules, biologics, hormones, metabolites and biomarkers.

Regulatory-grade expertise

All methods validated under EMA and FDA bioanalytical method guidelines, with full GLP compliance and QA oversight.

Integrated workflows

Bioanalytical activities closely coordinated with toxicology, pharmacokinetics and dose administration teams.

Proven track record

Over 4.000 preclinical studies supported by our in-house analytical team with extensive industry experience.

Need a robust bionaalytical method for
your preclinical study? Our team will
develop and validate your method with
full regulatory support