LLP «GENERAL PHARMA»

LABORATORY FOR ANALYTICAL RESEARCH METHODS

The Laboratory of Analytical Research Methods of GENERAL PHARMA LLP provides the development of analytical methods or the modification on existing methods of chemical analysis for original and generic drugs. The laboratory uses modern instrumental methods of analysis, which guarantees the high quality of research and development.

The laboratory provides services on the development of methods for the analysis of active pharmaceutical ingredients and drugs at the stage of pharmaceutical development by HPLC:

• Quality control of pharmaceutical substances and medicinal products in accordance to regulatory documentation;
• Development of methods for quality control of substances and medicinal products in terms of identification (authenticity by retention time), foreign impurities, quantitative determination;
• Validation of analytical methods for pharmaceutical substances, medicinal products, raw materials and intermediates;
• Preparation of protocols and validation reports;
• Study on the stability of pharmaceutical substances and drugs;
• Input quality control of raw materials, excipients and reagents;
• Quality control of intermediate products and semi-products formed during the production of medicines;
• Confirmation on the structure of standard samples (RS) used for quality control of medicines: RM of the main substance, RM of impurities, working standards of the enterprise.

PRECLINICAL AND CLINICAL STUDIES

GENERAL PHARMA LLP provides consultations on preclinical and clinical trials for developers and manufacturers of medicines in the EAEU:

• Design the development of preclinical studies, drawing up plans along with the research center in accordance to the requirements and recommendations of international guidelines and regulatory standards;
• Preparation/assessment of accompanying materials and SOPs for research work in accordance to regulatory standards;
• Initiation and monitoring of preclinical studies;
• Preparation of reports on preclinical studies of medicines;
• Evaluation of accompanying materials for research reports;
• Preparation on literature reviews of preclinical / clinical studies in CTD format (CTD);
• Evaluation on literature reviews with the necessary corrections;
• Development on the main documents of clinical trials: protocols, investigator's brochures, sheets and informed consent forms.