Bioequivalence Studies

One-stop solution for GLP-certified bioequivalence studies: from study design to regulatory submission.

Kymos Group has extensive experience managing comprehensive GLP bioequivalence studies. We offer an end-to-end solution, working in alliance with reputed European clinical centers to conduct the in vivo phase and following EMA, FDA, and ANVISA guidelines.

Our laboratories in Barcelona (Spain) and Frankfurt (Germany) are equipped with an extensive pool of LC-MS instruments and follow the ICH M10 Bioanalytical Method Validation guideline. We offer narrow timelines and competitive sample prices (method development and validation is free of charge).

logos of EMA, FDA and Avisa showing that Kymos Group is inspected by them

One Stop Shop

Our one-stop solution for 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:

BIOEQUIVALENCE STUDIES MANAGEMENT

  • Study design and protocol writing
  • Submission to Ethics Committee and Health Authorities
  • Insurance contracting
  • Clinical center management and monitoring
  • Bioequivalence studies execution

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BIOEQUIVALENCE STUDIES REPORTING

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

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BIOANALYSIS FOR BIOEQUIVALENCE STUDIES

  • Method validation following the ICH M10 guideline
  • Long term stability
  • Sample analysis by:
    • LC-MS/MS and HRMS for small molecules
    • ICP-MS for metal/organometallic analysis
    • ELISA, ECLA, and RIA for small peptides

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SUPPORT ACTIVITIES TO BIOEQUIVALENCE STUDIES

  • Procurement of reference medication
  • IMPD review
  • Comparative dissolution profiles
  • Importation of reference and test products
  • Batch testing and batch release
  • Central lab testing
  • Pharmacovigilance
  • Sample storage

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ANVISA-certified Bioequivalence Studies

Kymos Group bioanalytical laboratory located in Barcelona (Spain) and our Partnered Clinical Centers are approved by ANVISA to conduct bioequivalence studies to be submitted to Brazilian authorities. We have established partnerships to offer a one-stop-shop solution to provide our clients with a reliable, cost-efficient, and streamlined regulatory process to market your generic products in Brazil.

  • Bioanalytical Expertise:

    Kymos Group’s decades of experience developing and validating bioanalytical methods.

  • Clinical Studies Experience:

    Our partners’ proven track records in Phase I clinical studies ensure high quality and compliance.

  • End-to-End Service:

    From study design to regulatory submission, we provide a fully integrated, efficient, and reliable service.

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:

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Why Choose KYMOS?

  • Regulatory Excellence:

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

  • Global Trust:

    • Trusted partner for bioequivalence studies by leading generic manufacturers worldwide.

  • Extensive Expertise:

    • Proven experience of decades developing and validating bioanalytical generic methods.

  • State-of-the-art equipment and techniques

    • Large pool of equipment for small molecule bioanalysis and wide variety of instrumental techniques to manage every project.

Services

Related services to Bioequivalence Studies

Sample preparation biology bioanalytics

Bioanalysis of Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

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®.

Small molecules

Bioanalysis of Small Molecules & Generics

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

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