Laboratory of analytical research methods
The Center includes laboratories of analytical research methods to conduct analytical support of referenced medicinal products and generics based on the usage of modern instrumental analytical methods, development of new or modification of existing methods of chemical analysis, validation, and regulatory documentation preparation.
The main research subjects are active pharmaceutical ingredients, excipients and dosage forms. The laboratory is equipped with modern highly accurate measurement tools, following standards to guarantee the high quality of researches.
Analytical research approaches
- Quality control of pharmaceutical substances and medicines in regard with regulatory documentation;
- Development of quality control methods for substances and medicinal products ;
- Analytical methods validation of pharmaceutical substances and medicines, preparation of protocols and validation reports;
- Pharmaceutical substances and medicines stability learning;
- Incoming quality control of raw materials, excipients and reagents;
- Quality control of intermediate products, occurring in the process of medicines manufacturing;
- Establishing terms and expiration dates of substances and medicines.
The Center’s mission is to ensure the high-level quality projects to develop new medicinal products, including highly qualified assessment and projects administration on the stages of brainstorming, developing, preclinical and clinical researching.
The Center performs the following types of services in terms of the stated activity area:
- Researches organization and support for developers and manufacturers of medicines:
- Choice of the appropriate research base for conducting efficacy studies and/or safety in terms of medicine profile;
- Choice of the appropriate research base based on the price to quality ratio;
- On-site assessment of research base regarding the compliance with specifics and peculiarities of preclinical researches planned to be conducted;
- Design development of preclinical researches, plans execution together with the research center in terms of international and national guidelines and regulatory standards’ requirements and recommendations;
- Arrangement/ assessment of supplementary materials and SOP standard operating procedure to work on researches in terms of regulatory standards;
- Initiation and monitoring of pre-clinical researches;
- Reports assessment of pre-clinical medicines researches;
- Supplementary materials assessment to the researches reports;
- Arrangement of literature review in the CTD format;
- Assessment of literature reviews with necessary amendments;
- Pre-clinical researches consultations and projects administration until the moment of reports affirmation in the regulatory authorities;
- Tentative forecast of pre-clinical researches results to be used in a clinic;
- Advisory support of relevant articles preparation for their further publication.
- Assessment of scientific potential and accurateness of paperwork, included into the structure of registration dossier for medicinal products (reports of pre-clinical and clinical researches, literature reviews, manufacturer’s monograph, investigator’s brochure etc.) when making their buy and sell deal.
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