Center for development of scientific-research and medical activities
The main activity of the Center for medicines development (Center) is the conduct of scientific-research, design and experimental works on the development of new medicines, the implementation of applied scientific research in the field of pharmacology.
In the laboratory for the development of innovative medicines, which forms a part of the Center, the development of both, original drugs and generics, is being carried out in various dosage forms:
- oral (tablets, including coated, capsules, solutions, syrups, gels);
- injection (ampoules, cartridges, vials);
- soft dosage forms for external use;
- solutions for external use.
The laboratory carries out the development of NTD on preparations and transfer of technology to the production site.
The Center also includes a laboratory for analytical methods of research, which provides analytical support for the development of original drugs and generics, based on the use of modern instrumental methods of analysis, the development of new or modification of existing methods of chemical analysis, validation, preparation of regulatory documentation.
The main objects of research are active pharmaceutical ingredients, excipients and dosage forms.
The laboratory is equipped with modern high-precision measuring equipment meeting the standards that guarantee high quality of research.
Fields of analytical research:
- quality control of pharmaceutical substances and drugs in accordance with regulatory documents;
- development of methods for quality control of substances and drugs;
- validation of analytical methods of pharmaceutical substances and drugs, preparation of protocols and validation reports;
- studying the stability of pharmaceutical substances and drugs;
- input quality control of raw materials, excipients and reagents;
- quality control of intermediate products and semi-finished products formed in the process of drugs production;
- setting the conditions and terms of substances and drugs storage.
Center activity’ goal is also to ensure a high-level quality of projects on new medicines creation, including a highly qualified evaluation and support of projects at the stages of an idea, development, preclinical and clinical research. Within the framework of this activity area, the Center performs the following types of services:
1. Organization and support of research for developers and manufacturers of medicines:
- selection of the optimal research base for carrying out efficacy and/or safety studies in accordance with a drug profile;
- choice of the optimal research base for the price/quality ratio;
- on-site evaluation of the research base on compliance with the specifics and particular features of preclinical studies planned for implementation;
- development of preclinical research design, drawing up plans jointly with the research center in accordance with the requirements and recommendations of international and domestic guidelines and regulatory standards;
- preparation / assessment of accompanying materials and SOP for research work in accordance with regulatory standards;
- initiation and monitoring of preclinical research;
- evaluation of reports on drugs’ preclinical studies;
- evaluation of accompanying materials for research reports;
- preparation of literary reviews in the CTD (OTD) format;
- evaluation of literary reviews with the necessary amending;
- consultations on preclinical research and projects support until the approval of reports in regulatory bodies;
- preliminary prediction of the preclinical studies results for applying in the clinic.
2. Consulting support in preparation of field articles for subsequent publication.
3. Evaluation of scientific potential and correctness of formation of documentation, which is included in composition of the registration dossier for drugs (Reports on preclinical and clinical studies, Literary reviews, FSP, Investigator’s brochures, etc.) while making a transaction for the purchase and sale of drugs.