Analytical Methods
At this stage, analytical methods are developed and validated to ensure dosing formulations are administered at the intended concentration, with confirmed homogeneity and stability. Validation under GLP principles assesses accuracy, precision, linearity, specificity, and reproducibility, ensuring the integrity of dosing solutions and supporting the scientific validity and regulatory compliance of toxicology studies.
Established — 2000
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Our team designs and validates tailored analytical methods to support a wide variety of formulations, from conventional small molecules to complex biologics or advanced therapies, ensuring accuracy and reproducibility across preclinical programs. This process is essential to confirm the stability and integrity of the test item, generate reliable data, and meet the stringent requirements of regulatory submissions.
We develop customized formulations based on the physical and chemical properties of each test item. Our experts assess factors such as solubility, stability, viscosity, and compability with dosing routes and animal models. Once defined, the team validates the methods to confirm consistency in concentration, uniformity, and stability under specific storage and usage conditions. All procedures are executed in GLP-certified facilities, with full traceability and documentation to support regulatory submission.
Biotechnology
Chemical
Cosmetics
Advanced Therapies Medicial Products (ATMPs)
Our analytical laboratories are equipped with high-precision balances, vortex mixers, sonicators, temperature-controlled chambers, and GLP-qualified HPLC and LC-MS/MS systems for quantification. All processes are documented through validated digital systems to ensure traceability, integrity, and reproducibility.
In addition, we operate a wide range of chromatography systems, including Agilent GC 7890A and GC 6890A (with TCD and FID detectors), as well as Agilent HPLC LC 1200 and LC 1260 series (with UV, diode-array, and variable wavelength detectors). This comprehensive equipment portfolio allows us to adapt to diverse analytical needs across small molecules, complex formulations, and advanced therapies.
Extensive experince in handling poorly soluble compounds, as well as developing and working with nanoparticles, emulsions, and biologics.
All formulation methods are validated under OECD and GLP standards, with QA oversight and audit trails.
Close collaboration with toxicologists, technical team, and study directors to ensure study alignment and delivery.
Agile project execution with in-house method adaptation to meet study timelines and changes in formulation strategy.
Need a robust formulation method for
your next study? Our team will design,
validate and document your dosing
solutions under full GLP compliance
