We provide a full range of consulting services for registration and re-registration of medicines, pharmaceutical substances, biologically active additives, medical products, cosmetics in the Republic of Uzbekistan. As well as services for Pharmacovigilance of products.
The list of Services provided: Consulting on registration of medicines; Preparation of a registration plan and a list of necessary documents; Adaptation of documentation provided by foreign partners to the requirements in the Republic of Uzbekistan; Development of regulatory documentation for medicines; Development of instructions for the medical use of medicines (Ru and Uzb); Preparation of layouts of primary and secondary packaging (CDR, primary and secondary 3D packaging); Development of analysis methods (Adaptation of USP/BP); Formation of registration dossier; Submission of the registration dossier to the authorized executive body carrying out state registration of medicines; Organization and conduct of comparative studies; Support of the registration process; Obtaining permits, decisions and official requests from the authorized executive body carrying out state registration of medicines; Preparation of additional materials in accordance with the requests of the authorized executive body carrying out state registration of medicines funds; Obtaining a registration certificate and approved documentation (ND, instructions for medical use, packaging schemes) for a medicinal product; Consultation on registration of the marginal price.
The list of services provided: Checking the composition of Biologically Active Additives for compliance with the current Technical Regulations. Formation of a general dossier on products. Submission of dossiers and samples of Biologically Active Additives to the institution authorized to conduct registration tests. Processing of test results, obtaining protocols. Expert support of tests: timely introduction of the required changes, correction of the dossier in accordance with the requirements of experts. Obtaining an expert opinion. Completion and submission of documents. Obtaining a certificate of state registration of Biologically Active Additives.
The list of services provided: Consultations on the inclusion of a pharmaceutical substance in the State Register of Medicines; Preparation of a plan for the inclusion of a pharmaceutical substance in the State Register of Medicines and a list of necessary documents; Adaptation of documentation provided by foreign partners to the requirements of the Republic of Uzbekistan; Development of regulatory documentation for a pharmaceutical substance; Formation of a registration dossier; Submission of the registration dossier to the authorized executive body carrying out state registration of medicines; Support of the process of inclusion of pharmaceutical substances in the State Register of Medicines; Obtaining permits, decisions and official requests of the authorized executive body carrying out state registration of medicines; Preparation of additional materials in accordance with the requests of the authorized executive authority carrying out the state registration of medicines; Obtaining a Decision on the inclusion of a pharmaceutical substance and approved documentation (ND, packaging layouts) for a pharmaceutical substance.
The list of services provided: Development of a research program, preparation of: regulatory documentation (ND), technical documentation (technical specifications, technical regulations), operational documentation (operating manual, operating instructions, instructions for use), labels; Organization and monitoring of technical and toxicological tests, as well as planning and conducting clinical trials of products medical purposes, including obtaining permission for clinical trials in authorized bodies; Preparation of a package of documents for registration in accordance with the applicable requirements, registration of an application for registration; Submission of documents to the Registration Authority; Monitoring of the examination of the quality, effectiveness and safety of medical devices; Accompanying the passage of documentation in order to obtain a Registration certificate of medical devices and obtaining a Registration certificate.
The list of services provided: Analysis of current documentation; Development or bringing documentation into compliance with legal requirements; Development of standard operating procedures; Development and implementation of safety measures; Constant monitoring of the safety of medicines on the market; Reporting on cases of adverse events and reactions; Preparation of periodic reports on the safety of medicines; Conducting trainings and seminars on pharmacovigilance.