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

Let’s Talk

CLINICAL STUDY MANAGEMENT

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

Let’s Talk

CLINICAL STUDY MANAGEMENT

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

Let’s Talk

CLINICAL STUDY MANAGEMENT

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

Let’s Talk

Wir bieten eine umfangreiche Liste validierter Methoden für die Bioanalyse* an.

*Falls Sie die gesuchte Methode nicht finden, kontaktieren Sie uns bitte trotzdem, da wir die Validierung generischer Methoden kostenlos anbieten.

Sie können die vollständige Liste der Methoden herunterladen:

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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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