Bioanalysis of Small Molecules & Generics

GLP-certified & GCP-compliant bioanalysis for preclinical, clinical, and bioequivalence studies

Kymos Group specializes in world-class bioanalysis of small molecules, offering a comprehensive range of services from fast in vivo and in vitro ADMET screenings to pre-clinical toxicokinetics, bioavailability and pharmacokinetic studies, drug-drug interaction studies, and clinical trials including first-in-man and dose escalation studies.

Our bioanalysis experts are experienced in comprehensively managing pre-clinical and clinical bioanalysis of small molecules from phases I to IV and bioequivalences for generics. We are a GLP-certified and GCP-compliant multinational CRO with broad experience catering to various client profiles, including:

  • Large generics companies seeking full bioequivalence studies.
  • Small biotech innovators conducting basic research and development (R&D).

  • Animal health firms requiring residue depletion studies.

Bioanalysis Laboratorium
Kymos LC-MS-MS Sciex

Services

Our catalog of services include:

Preclinical studies of small molecules

  • Phase I-IV pharmacokinetics including first-in-man dose escalation studies
  • Drug-drug interaction studies
  • Identification and quantification of biomarkers and pharmacodynamics
  • Comprehensive bioequivalence generic studies working in alliance with reputed European preclinical and clinical centers following EMA/FDA/ANVISA guidelines

  • In vitro percutaneous absorption studies to test how small molecules as topical drugs absorb and break down through the surface of the skin and synthetic membranes.

  • Comprehensive study management with strategic partners for pre-clinical experimentation and animal housing
  • Veterinary drug validation with various animal models and complex matrices such as liver, fat, muscle, brain, milk, honey, or eggs

  • Absorption studies for dietary supplements and phytopharmaceuticals, measuring effects and absorption rates in living organisms
  • Expertise in bioanalysis of small molecules in clinical studies of nutraceuticals, medical devices, and phytopharmaceuticals
  • Specialized in developing complex bioanalytical methods for challenging matrices, low LOQ, and multiple analytes

One Stop Shop

One-stop solution for preclinical, clinical, and bioequivalence studies

Kymos Group is fully coordinated with our alliance partners offering high-quality standards, narrow timelines, and competitive prices to provide a one-stop shop service in the following areas:

CLINICAL STUDY MANAGEMENT

  • Protocol writing
  • Submission to Ethics Committee and Regulators
  • Insurance contracting
  • Clinical center management and monitoring
  • Study execution
  • Sample shipment and storage

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STUDY REPORTING

  • Phoenix WinNonlin® data analysis
  • Pharmacokinetic report
  • Final clinical report
  • Specific reports to Authorities requests

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BIOANALYSIS

  • LC-MS/MS and HRMS for small molecules, generics
  • ICP-MS for metal/organometallic analysis
  • ELISA, ECLA and RIA for small peptides

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SUPPORT ACTIVITIES

  • IMPD writing or review
  • Analytical testing for stability studies
  • Comparative dissolution profiles
  • Importation of reference and test products
  • Batch testing and batch release
  • Physical-Chemical analysis of administration solutions/formulations

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We offer an extensive list of validated methods for bioanalysis*

*If you do not find the method that you are searching for, please contact us anyway since we offer the validation of generic methods for free.

You can download the complete list of methods:

Ready to accelerate your drug development? Let’s tailor the perfect solution for you!

Ask our experts

Team Discussion

Why Choose KYMOS?

  • Regulatory Excellence:

    • FDA, EMA, and ANVISA inspected, GLP-certified, and GCP-compliant.

  • Global Trust:

    • Trusted partner for bioanalysis of small molecules by leading companies worldwide.

  • Extensive Expertise:

    • Proven experience in developing proprietary methods from kick-off to market launch.
    • Specialized in handling challenging projects involving unstable compounds, multiple metabolites, endogenous compounds, strong matrix effects, and extremely low LOQs.

  • State-of-the-art equipment and techniques

    • Large pool of equipment for small molecule bioanalysis and wide variety of instrumental techniques to manage projects with high sample volumes effectively.
    • Equipped with UHPLC- and HPLC-MS/MS (Sciex API 6500+, API 5500, API4000, API3200, and Agilent 6490), UPLC-HRMS (QTof Xevo G2S) and ICP-MS (Agilent 7700 and 7800).

Services

All Pre-clinical & Clinical Bioanalysis Services

Oligo testing

Bioanalysis of Nucleic Acids

Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

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

Percutaneous Absorption

Percutaneous Absorption

Percutaneous absorption assays for topical semisolid drug products: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT)

LC-MSMS Sciex API 5500 QTrap

Bioequivalence Studies

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

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