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  • Блог по регистрации, разработке, изучению лекарственных средств
  • канал о регистрации, разработке, изучению лекарственных средств

Expert development, research, and registration of medicinal products in compliance with EAEU (Eurasian Economic Union) procedures — covering Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia.

I am Dmitry Romodanovsky, an expert in pharmaceutical regulation with over 17 years of experience. I provide consulting services on drug development, regulatory strategy planning, preparation of documentation for clinical trials, and auditing of regulatory dossiers.

Our Services

I will share my method

How to save time and money throughout the entire drug development and registration cycle. Most mistakes, sometimes irreversible, occur at the early planning stage of drug development.

Former state expert

From 2007 to 2021, I worked at the Federal State Budgetary Institution “Scientific Center for Expert Evaluation of Medicinal Products” under the Russian Ministry of Health, starting as a specialist and advancing to the position of chief expert.

My own proprietary scientific technology

I participated in drafting documents for the Eurasian Economic Union, including the regulations on bioequivalence studies of medicinal products.

Personal scientific achievements

PhD and Doctoral dissertations.
Over 50 publications.
Co-author of several monographs on drug research.

Three ready-made solutions.

A ready-to-use database of reference drugs that have been previously approved.
A fully developed and calculated study design.
A finalized recommendation.

Quick start – reliable and official.

Contract signing and separate payment for each stage.

Saving time and budget

I will offer you the most beneficial options.

Client Results:

Every clinical trial design I developed has been approved, allowing clients to reduce the timeline from planning to report completion by 2 months.

Certificates

Drug registration and clinical pharmacology.
Drug development and Good Laboratory Practice (GLP).
Preparation of documentation for clinical drug trials
Audit of regulatory dossier documentation.
Consultations on drug development and regulatory strategy determination
Evaluation of drug bioequivalence

Leave a request.

Phone

+7 993 260 72 49

E-mail

Social media.

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Saving time and money!

Thanks to my extensive experience as a regulator, I can quickly identify potential issues with your product and develop an effective strategy to achieve fast results with minimal risks. This will help reduce the time required for preparation, drug research, document drafting, and regulatory compliance.

I can minimize the number of inquiries and speed up responses by leveraging my expertise in document correction and regulatory communication. I also offer the most cost-effective conditions for conducting studies with accredited companies, optimizing the research volume necessary for drug registration under EAEU regulations.

запись на консультацию по 
разработке, изучению и регистрация лекарственных препаратов

Sign up for a consultation.

Free consultations – every Tuesday from 14:00 to 17:00.
Paid consultations – available on other business days from 12:00 to 17:00, at a cost of 15,000 RUB.

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