Bioanalysis for Animal Health

GLP bioanalytical services for veterinary drug development, bioequivalence studies, and residue depletion studies

Veterinary medicines require the same scientific rigor and regulatory precision as human therapeutics but demand unique analytical approaches adapted to diverse species, complex matrices, and specific regulatory frameworks.

At Kymos Group, we provide GLP-compliant bioanalytical services dedicated to Animal Health, supporting the development of innovative products, bioequivalence, and residue depletion studies of veterinary drugs. Our multidisciplinary teams combine extensive LC-MS/MS expertise with a deep understanding of veterinary-specific regulations to deliver reliable data for global submissions.

Operating under GLP certification and inspected by both the EMA and FDA, our laboratories ensure full regulatory acceptance and high-quality results across all species and study types.

Analytisches CRO LC-MS/MS API 6500

MAIN Services

Our Bioanalytical Services for Animal Health

Kymos supports veterinary drug development with GLP-compliant bioanalytical services across all key study types. Our expertise ensures reliable, regulatory-compliant data for:

  • Residue Depletion Studies:
    GLP analysis to establish withdrawal periods and maximum residue limits (MRLs), following VICH GL49 (2012) to ensure compliance with international food safety standards.
  • Bioequivalence Studies:
    Demonstration of equivalence between generic and reference veterinary products, using EMA/FDA-validated bioanalytical methods.
  • Additional Services:
    • Pharmacokinetic and toxicokinetic studies
    • Metabolite identification and characterization
    • Stability testing and storage monitoring
    • Method transfer and cross-validation
    • Sample analysis across multiple complex matrices

Our experience

Animal Species and Matrices

Target Animal Species

Our bioanalytical teams have extensive experience working with a wide range of target animal species, including:

  • Cat
  • Dog
  • Horse
  • Cattle and cow
  • Sheep
  • Goat
  • Pig (including neonatal models) and minipig
  • Poultry
  • Marine and freshwater fish

This diversity allows us to adapt our methods to the specific physiological and regulatory requirements of each species, ensuring robust, compliant data generation.

Matrices and Sample Expertise

We have developed and validated analytical methods across a broad spectrum of complex biological matrices, including:

  • Plasma of different complexity levels
  • Whole blood
  • Liver
  • Fat
  • Muscle
  • Kidney
  • Spleen
  • Brain
  • Milk
  • Honey
  • Eggs

Our scientists apply advanced extraction and clean-up techniques to manage matrix interferences and achieve trace-level quantification with high reproducibility.

SERVICES

Our One-Stop-Shop Solution

At Kymos, we offer a streamlined, end-to-end solution for veterinary studies. Through strategic partnerships with GLP-certified in-vivo centers, we manage the full package, from in-life dosing to sample analysis and reporting.

  • Single-point coordination across the entire study-chain ensures reduced complexity and faster timelines.
  • Fully traceable data from animal dosing through bioanalytical results, enhancing consistency and regulatory readiness.
  • Designed for veterinary generics and reference products in target species, in full compliance with EMA/FDA standards for animal health.
Team Discussion

Why Choose KYMOS?

  • Regulatory Excellence:

    • Compliance with VICH GL49 (2012) for residue depletion and EMA/FDA bioanalytical validation guidelines for PK and bioequivalence ensures global regulatory acceptance.

  • GLP-Certified & Inspected:

    • Our laboratories operate under GLP, inspected by EMA and FDA, guaranteeing the reliability and reproducibility of all analytical data

  • Advanced Analytical Platforms:

    • State-of-the-art LC-MS/MS instrumentation enables ultra-sensitive quantification of drugs, metabolites, and residues in complex matrices.

  • Trusted by Global Leaders

    • For over two decades, Kymos has partnered with leading veterinary pharmaceutical companies to support drug approvals, residue depletion studies, and bioequivalence programs.

Services

Related services to Animal Health

Small molecules

Bioanalysis of Small Molecules

Development and validation of analytical methods for analysis of biological samples delivered mainly from pre-clinical and clinical studies.

Kymos LC-MS-MS Sciex

Bioequivalence Studies

Bioanalysis for bioequivalence studies of generics in collaboration with the sponsor and/or the selected clinical phase centre.

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin.

Contact

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