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Experience, Quality, Reliability

Clinical Trials
in Belarus

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Experience, Quality, Reliability

Registration of Drug Products and Medical Equipment

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Clinical Trials

Clinical Trials in the territory of the Republic of Belarus are conducted in full concordance with GCP requirements. ALPHALEK provides the full suite of services, from the elaboration of protocol to the preparation of final report, and ensures that clinical trials are conducted at a scheduled time.

Bioequivalence Studies

Bioequivalence Studies in the Republic of Belarus are conducted in accredited Centers and Testing Laboratories. Our company delivers services concerning the preparation of all required study documents and their approval by regulatory authorities and study centers. We supervise the study conduct at all stages.

Registration of Drug Products

ALPHALEK’s staff has a great experience in the practice of drug products registration. We offer our support to pharmaceutical companies in the territory of the Republic of Belarus and the Eurasian Economic Union.

Registration Medical Equipment

ALPHALEK renders services associated with the registration of medical equipment and medical devices in the territory of the Republic of Belarus and the Eurasian Economic Union.

Pharmacovigilance in the Republic of Belarus

ALPHALEK’s professionals have the appropriate qualification and adequate knowledge of pharmacovigilance activities. These skills enable us to be a pharmacovigilance contact partner in the Republic of Belarus for many European pharmaceutical companies.

Statistical Data Analysis

Our statisticians are involved in the clinical trial throughout all stages. The correct determination of study design, end-points, sample size and methods of statistical processing is the indispensable prerequisite to obtain reliable results.

Dossiers in CTD fotmat

The set of ALPHALEK’s services includes the arrangement of registration dossier in CTD format (modules 2, 4 and 5).

Medical Translation

The translation of documentation on medical and pharmaceutical topics requires not only the mastery of a language but also the in-depth knowledge in the medical field. Our specialists have translated hundreds of texts making part of registration dossiers.

ABOUT OUR COMPANY

ALPHALEK offers services related to the conduct of clinical trials and bioequivalence studies in the territory of the Republic of Belarus as well as the registration of drug products and medical equipment.