PHARMBIOTEST is a state-of-the-art unit of 4500 square meters, and meeting international standards to provided pharmacokinetic and bioequivalence services to our clients.
Our large clinical site is located on the third floor of Medical Center, furnished with 36 beds. It is fully equipped with facilities for safety and well-beings of the study subjects. The clinical unit is equipped with a dining area, recreation zone, wards, washrooms, and lockers for personal belongings. Our Center studies are supervised by an emergency-medicine-trained physician around the clock and there is immediate access to the intensive care unit of Local Hospital.
Our bioanalytical unit is fully equipped with the state-of-the-art facilities. Our analytical staffs have expertise in method development and validation of bioanalytical methods for biological samples analysis.
We conduct clinical study in a well-controlled environment on healthy human subjects in accordance with ICH-GCP guidelines.
PHARMBIOTEST has a systematic quality assurance as separate unit to assure that each phase of the study will be performed according to ICH-GCP and OECD-GLP guidelines, study protocols, internal SOPs and relevant regulatory requirements. All data obtained from the study is validated and verified through a data monitoring system.
Our clinical staffs are well-trained and highly qualified for their duties.
All of our capable and fully qualified staff in many fields are one of the key success factors to your Bioequivalence study. Our operations team including research and development, bioanalytical team and clinical research team have been well-trained for operating both software and advanced equipment as well as understanding the BE process thoroughly. Hence, we are able to provide you the best service according to the Ukraine legislation in bioequivalence study and compliance to the Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
Our team will work closely with every team at each stage of your study, from initiation to completion, to be able to run smoothly and effectively. The report will be generated accurately and precisely to ensure that all studies have been appropriately designed and followed.
Clinical research team will adhere strictly to ICH-GCP guidelines for all clinical activities including subject recruitment, screening, dosing and collecting of biological samples.
Our high qualified and well-trained bioanalytical team will serve you on developing and validating bioanalytical methods that are accurate, precise, selective, sensitive and reproducible. Our proficiency is constantly upgraded to meet requirements for new generic drug approvals. All process of BE study will be internally audited by QA team which work independently from other department to assure our quality assurance system.
With enthusiasm, professional team effort, and technologically advanced equipment brings PHARMBIOTEST as one of the international professional company in Bioequivalence study.