+7 996 716 83 66
Researches
Preclinical and clinical studies are conducted to enable the registration of medicines. MPM Adviser provides services aimed at organizing high-quality and objective conduct of such studies, as well as consulting on compliance of testing laboratories and centers with GLP requirements.
Work Stages
Strategy for conducting preclinical studies of various medicines and medical devices
Development of detailed programs for conducting preclinical studies for further drug registration
Development of programs to study the properties of medicines in order to expand the scope of medical use
Optimization of existing projects in order to reduce the duration of research and budget
Consulting services in the planning and organization of preclinical studies
Development of programs to study the properties of medicines in order to expand the scope of medical use
Optimization of existing projects in order to reduce the duration of research and budget
Consulting services in the planning and organization of preclinical studies
Projects Scientific Analysis
Working with pre-clinical research reports or projects already available
Assistance in drafting project documentation: terms of reference, scientific justification of the project, etc.
Own evaluation of research results and preparation of recommendations for planned clinical trials
Consultations on the selection of performers (testing centers) for specific studies
Assistance in drafting project documentation: terms of reference, scientific justification of the project, etc.
Own evaluation of research results and preparation of recommendations for planned clinical trials
Consultations on the selection of performers (testing centers) for specific studies
External Control and Support of Preclinical Studies
Legal study, control of organizational issues
Highly qualified quality control of the study in accordance with the GLP requirements
Control of the welfare of laboratory animals – control measures for the rational and prudent use of laboratory animals, detention conditions control, painful procedures control
Justification control of the doses choice, the choice of the biological type of laboratory animals, proofreading of the final report and other issues related to the scientific part of the study – according to the guidelines for conducting preclinical studies and other methodological manuals
Highly qualified quality control of the study in accordance with the GLP requirements
Control of the welfare of laboratory animals – control measures for the rational and prudent use of laboratory animals, detention conditions control, painful procedures control
Justification control of the doses choice, the choice of the biological type of laboratory animals, proofreading of the final report and other issues related to the scientific part of the study – according to the guidelines for conducting preclinical studies and other methodological manuals
Registration Dossier Preparation
Bringing registration dossiers in accordance with the requirements of the EAEU (Decision No. 78)
Work with existing reports and other research documents – assessment of the sufficiency of the implemented program of preclinical research, verification of reporting documentation
Preparation of literature reviews on preclinical studies (for reproduced and any other products) – both for registration and for expanding the knowledge base about the product
Assistance in the preparation of documentation: summary reports, brochures of researchers and other documentation in the format of a common technical document (OTD) – in accordance with Decision No. 78 of the EEC
Work with existing reports and other research documents – assessment of the sufficiency of the implemented program of preclinical research, verification of reporting documentation
Preparation of literature reviews on preclinical studies (for reproduced and any other products) – both for registration and for expanding the knowledge base about the product
Assistance in the preparation of documentation: summary reports, brochures of researchers and other documentation in the format of a common technical document (OTD) – in accordance with Decision No. 78 of the EEC
Contact Us
Phone/Whatsapp/Telegram
+7 996 716 83 66
E-mail
info@mpmadviser.com
