Services and Pricing
Comprehensive solution
Full product support from the development stage to the registration stage.
I handle all matters related to recommendations for proper product development in accordance with the EAEU rules, all aspects of document preparation for drug studies, and the preparation of the product dossier (Common Technical Document). If necessary, I submit the dossier. I provide support throughout the expert evaluation process until the drug is registered, and I assist in properly responding to regulator inquiries according to EAEU requirements. After obtaining the registration certificate, if any changes need to be made to the documents of the Common Technical Document, I will help prepare the necessary documents and, if required, submit the updated dossier.
Cost in Russian rubles:
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Preclinical and clinical research stage – from 250,000 rubles
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Post-clinical and preclinical research stage – from 150,000 rubles
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Pre-registration stage – from 500,000 rubles
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During registration stage – from 150,000 rubles
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Post-registration stage – from 150,000 rubles
After signing the agreement, payment for each stage is made separately (50% advance payment, 50% after the completion of work for each stage).
Private solutions
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Consulting and auditing for drug registration
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Document preparation (clinical section of CTD – Common Technical Document; document package for clinical trials; preparation of clinical trial result reports; writing IMP – Investigational Medicinal Product, SmPC – Summary of Product Characteristics, API – Active Pharmaceutical Ingredient)
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Document review and revision (clinical section of CTD; document package for clinical trials; clinical trial report; IMP, SmPC, API)
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Training on regulatory requirements, clinical dossier composition, and drug documentation preparation;
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Training on development and study requirements for generic drugs.
Investment consulting
Evaluation of the feasibility of developing a pharmaceutical product (including at early stages) and the potential of a molecule based on its primary properties and proposed mechanism of action, initial data audit, and overall assessment of the development program considering current requirements (Russia, EAEU, EU).
Development strategy formulation
Determining the scope and sequence of preclinical and clinical studies, as well as identifying missing pharmaceutical and biological tests. Selection of a comparator drug and description of key elements in the design of registration studies: superiority, non-inferiority, equivalence, and more.
Comprehensive consulting on the current state of affairs
Assessment of the adequacy of the registration dossier or clinical trial dossier; correlation of preclinical data with pharmaceutical data at any stage, with a list of recommendations for improvements; creation of an objective overview; assistance in selecting further strategies based on the chosen scenario and registration/post-registration lifecycle pathway.
Scientific and regulatory consulting for applicants in preparing responses to inquiries from regulatory authorities and expert organizations
Scientific and regulatory consulting for applicants in preparing responses to inquiries from regulatory authorities and expert organizations: interpretation and clarification of expert and regulatory comments, development of a response strategy, and formulation and defense of the applicant's/marketing authorization holder’s position.
I also offer you three ready-made solutions