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Conducting a clinical trial is a complex, multicomponent process that requires special attention to training and specialized knowledge in the implementation.
Bioequivalence studies of medicinal products are required to confirm the effectiveness and quality of drugs at various stages of drug delivery to the market, from the application for registration of the drug.
We follow the ICH GCP rules and assign all the work related to the application of statistical methods to a qualified biostatistics specialist.
An important component of the clinical trial process is the proper collection, storage and processing of data.
Preparation of clinical research documents requires not only knowledge of special requirements, but also the experience of scientific activity.
One of the directions of our activity is the provision of services for the registration of pharmaceuticals, biologically active additives, medical devices and medical equipment in Belarus.
The organization and maintenance of pharmaceutical pharmacovigilance systems in the Republic of Belarus is a prerequisite for its presence on the market of medicines in Belarus.
In the process of coordinating clinical trials and registering drugs and medical products, a large volume of material is required.
Effective withdrawal of drugs to the pharmaceutical market in Belarus requires the formation of a certain strategic position - the tactics of pharmaceutical marketing, and in some cases may include the conduct of pharmacoeconomic studies.