Bioequivalence Studies

Our bioanalysis experts are experienced in the comprehensive management of bioequivalence studies, offering end-to-end service from IMPD review to final reporting. We work in alliance with reputed European clinical and preclinical centers following EMA and FDA guidelines. High-quality standards, narrow timelines and competitive prices are key elements for our delivery. We are fully coordinated with our alliance partners to provide One Stop Shop services for bioequivalence studies in the following areas:

Bioequivalence - clinical studies

CLINICAL STUDY MANAGEMENT

STUDY REPORTING

  • Protocol writing
  • Submission to Ethics Committee and Regulators
  • Insurance contracting
  • Clinical center management and monitoring
  • Study execution
  • Plasma sample shipment and storage
  • Phoenix WinNonlin® data analysis
  • Pharmacokinetic report
  • Final clinical report
  • Specific reports to Authorities requests

BIOANALYSIS

SUPPORT ACTIVITIES

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

Our experts can transfer existing bioanalytical methods and have a long list of validated methods offering the Clients the opportunity of directly analyzing their samples thereby saving time and money. If one is not available, we can develop and validate the method free of charge in a timely manner.

WE OFFER AN EXTENSIVE LIST OF VALIDATED METHODS

In case you are not able to find the analytical method you need, please contact us. Our experts will check if we can develop the method for you or add it to our validated method list.

DO YOU NEED MORE INFORMATION OR A QUOTE?

Related Services

Bioanalysis of Biologics and Biosimilars

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

Bioanalysis of Small Molecules

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

Pharmacokinetics

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

Nucleic Acids Analysis

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

Get in touch


    EU Sites

    Kymos Group

    Barcelona
    Spain

    Prolytic

    Frankfurt
    Germany

    Pharmaprogress

    Ancona
    Italy

    EU Offices

    Paris
    France

    Basel
    Switzerland

    Milano
    Italy