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.

Services

Bioanalysis of Small Molecules & Generics

Our comprehensive services include bioequivalence studies, biomarker analysis, PK evaluation, and biodistribution and immunogenicity, supported by advanced platforms like LC-MS/MS and Meso QuickPlex SQ.

Preclinical studies of small molecules

Clinical studies of small molecules

Percutaneous absorption

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Residue depletion studies

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Absorption studies

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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:

Download method list (.pdf)

Validated Methods for bioanalysis

Our extensive list of validated methods is available for download. If you cannot find your desired method, we develop and validate methods free of charge for generics.

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Why Choose KYMOS?

Regulatory Excellence:

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