Детали в разделе "Контакты"

Development of the Active Pharmaceutical Ingredients

A separate unit of the company specialises in the development of medicinal drugs on the principle of a full cycle, from the molecule synthesis to the development of a finished dosage form.

Our experts are engaged in testing and deploying technologies in the industrial production, arrange for both pre-clinical and clinical research.

The scientific, technological and personnel potential of the company is aimed at manufacturing products that meet the most stringent international quality standards including the international standard ISO 9000.
Pre-clinical studies
The primary objective of the pre-clinical research department is the organization and execution of a wide range of tests of developed drugs. The research is aimed at studying the biological activity, toxicity, antioxidant, cytoprotective and other properties of pharmacological substances.

The department's work includes both the development and organisation of in vivo research, as well as various laboratory in vitro research methods including innovative research methods in mammalian cell cultures.

The department's laboratory functions include the development, validation and research of the specific activity of the developed drugs by using live cultures of mammalian cells and laboratory animals.

As a result of a series of conducted research, some reports and documents necessary for the registration of medicines are prepared.
Clinical research
The key objective of the department is to ensure that the clinical data are obtained during the registration and post-marketing clinical research.

As part of the project, the department carries out project planning, develops clinical research designs including the statistical part and a data management plan as well as input documentation, interacts with contracted research organisations, exercises control of the research progress and the quality of the results obtained.

In its work, the department applies the most recent project management techniques and focuses on the most relevant Russian and European clinical research requirements including the ICH good clinical practice requirements (ICH GCP). The department has developed and implemented a quality assurance system that meets this international standard.
Registration department
The main function of the registration department is to arrange for activities related to the effective development, management and updating of the company's global regulatory strategy.

Registration/re-registration of medicinal drugs, making changes to registration documents, obtaining permits for registration and post-marketing clinical trials, import/export of a specific batch of drugs for development in order to register, conduct clinical trials; pharmacovigilance systems, licensing permits.

The registration department manages regulatory risks in compliance with the existing laws of the Russian Federation and other countries, the provisions of regulatory and procedural documents on the effectiveness, safety and quality of drugs to achieve the company's approved strategic goals.
Детали в разделе "Контакты"