BIOEQUIVALENCE STUDIES

BIOEQUIVALENCE STUDIES

Kymos Group has extensive experience in the management of 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 located 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 validation is free of charge).

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BIOEQUIVALENCE STUDIES MANAGEMENT

BIOEQUIVALENCE STUDIES REPORTING

  • Study design and protocol writing
  • Submission to Ethics Committee and Health Authorities
  • Insurance contracting
  • Clinical center management and monitoring
  • Bioequivalence studies execution
  • Phoenix WinNonlin® data analysis
  • Pharmacokinetic report
  • Final clinical report
  • Specific reports to Authorities requests

BIOANALYSIS FOR BIOEQUIVALENCE STUDIES

SUPPORT ACTIVITIES TO 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
  • 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

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

The method list is not complete; some methods may be on-going or under revalidation. In case you are not able to find the product of your interest, please contact us.

Related Services to Bioequivalence Studies

Bioanalysis of Small Molecules

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

Pharmacokinetic Evaluation

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

Bioanalysis of Biologics and Biosimilars

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

Nucleic Acids Analysis

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

DO YOU NEED MORE INFORMATION OR A QUOTE?

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    Laboratories

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    Barcelona
    Spain

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    Frankfurt
    Germany

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    Ancona
    Italy

    Offices

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    Paris
    France

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    Milano
    Italy

    Branches

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    Seoul
    Korea