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

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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

Download method list (.pdf)

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.