1․1 Pharmacokinetic studies.

  • Bioavailability studies
  • Bioequivalence studies

Bioequivalence studies have become an essential requirement for registering new pharmaceutical products in markets across the world. We conduct cost-effective and high quality bioequivalence studies in short period of time.

BE Studies are conducted at Tonus-Les LLC are in strict Compliance with International Regulatory Requirements, monitored by an independent quality assurance department.

We provide full CRO service to conduct bioequivalence studies. We aim to become a valued partner for your pharmaceutical product research, development and registration.

PK studies in healthy volunteers: we can work with as many as 34 volunteers per study.


Types of dosage forms:

  • oral tablets
  • ODTs (orally disintegrating tablets), lozenges and drugs with sub-lingual administration
  • syrups and suspensions for oral administration
  • suppositories.

Our bioequivalence services include, but not limited to:

  • Protocol, CRF, ICF and other required documents’ development, review and management
  • Ethics committee and regulatory authority submissions
  • Translation of all pharmacokinetic study documents (to/from Armenian, English and Russian) according to the current medical terminology, including quality checks
  • Assistance in obtaining local insurance
  • Oversight of the pharmacokinetic trial for compliance with the protocol and applicable regulatory requirements
  • Timely subject recruitment
  • Reporting of study results
  • Closing out the study and ensuring records transfer
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