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  • Блог по регистрации, разработке, изучению лекарственных средств
  • канал о регистрации, разраб�отке, изучению лекарственных средств
Drug registration stage

Projects

Every clinical trial I’ve designed has received regulatory approval to proceed.

Over 50% of the drugs I’ve guided reached the Common Technical Document (CTD) preparation stage within 3 years.

24% of the drugs are now in the Marketing Authorization (MA) approval stage.

Stages of clinical trials and preparation of a drug dossier

Data is provided only for generic drugs. Information on original brand names, new combinations, and biological products is not included to maintain confidentiality.

If you're facing issues or have questions about your product, I'm ready to provide a free consultation or conduct an audit of your product development strategy.

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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