Bioequivalence Studies

We are experts in bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase centre. We have a long list of validated bioanalytical methods and when not available, we perform the method validation free of charge for our clients in a very short period of time. LIST OF VALIDATED METHODS.

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Moreover, we are also a well-reputed service provider for the comprehensive management of bioequivalence studies thanks to strategic alliances with reliable GCP-compliannt clinical phase centres. The main activities developed are:

  • IMPD review
  • Protocol writing
  • Obtention of EudraCT number
  • Submission of IMPD to the Agency and the Ethical Committee
  • Taxes payment
  • Insurance contracting
  • Sample labelling
  • Volunteers recruiting and associated documentation
  • Clinical analysis
  • Contracting of clinical center, previously audited and certified
  • Monitoring of clinical center during the study
  • Sample transportation
  • Bioanalysis of biological samples
  • pK calculations, statistics and bioanalytical report
  • Final study report

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KYMOS may offer you other related medicinal chemistry services, such as dissolution profiles, stability studies or quality control. This last activity includes Batch Testing and Batch Release of clinical batches.

KYMOS is authorized for Import drug products into the UE of non-European manufacturers, both for investigational and human use and may assist you in the medication procurement.

 

 

 

 

     

 

 

 

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