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:

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

Download method list (.pdf)

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.