top of page
  • Блог по регистрации, разработке, изучению лекарственных средств
  • �канал о регистрации, разработке, изучению лекарственных средств

Ready solutions

photo_2024-07-08_06-05-48.jpg

1

Ready solutions

Drug-specific recommendation for selecting a reference drug for bioequivalence studies.

2

Ready solutions

Drug-specific recommendation for bioequivalence study of a specific generic drug.

3

Ready solutions

Individual recommendation regarding the applicability of the biowaiver procedure.

Drug-specific recommendation for selecting a reference drug

1

This is an already established database of reference drugs that were previously approved by the Ministry of Health of the Russian Federation or approved in the decisions of the Expert Committee on Medicines of the Eurasian Economic Commission.

You only need to enter the required International Nonproprietary Name (INN) along with your contact details (name, company, position, phone, email), and if a reference drug for this INN already exists, you will immediately receive the ready information via email.

If the drug-specific recommendation you're interested in is not available, you can submit a request for the search and justification of a comparison drug, starting from 50,000 RUB.

Example of how a drug-specific recommendation looks: As a comparison drug in bioequivalence studies, it is recommended to use the drug Liprimar®, coated tablets 10, 20, 40, 80 mg (registration certificate No. LP-№(002230)-(RG-RU), holder of the registration certificate Viatris Specialty LLC, USA), which is listed as a reference in the Eurasian Economic Union's medicine registry, in accordance with paragraph "a", clause 18 of Decision No. 85 of the Eurasian Economic Commission Council.

Drug-specific recommendation for bioequivalence study.

2

This is a ready-made and calculated design based on my personal work. You only need to enter the required International Nonproprietary Name (INN), and if a drug-specific recommendation for this INN already exists, you can pay for the document (cost: 5,000 RUB), and the ready design will be sent to your email immediately.

If the drug-specific recommendation you're interested in is not available, you can submit a request to obtain the required design, with a cost of 15,000 RUB.

Пример как выглядит препарат-специфичная рекомендация:

Drug-specific recommendation for bioequivalence study.

2

This is a ready-made and calculated design based on my personal work. You only need to enter the required INN, and if a drug-specific recommendation for this INN already exists, you can pay for the document (cost: 5,000 RUB), and the ready design will be sent to your email immediately.

If the drug-specific recommendation you need is not available, you can submit a request to obtain the required design at a cost of 15,000 RUB.

Example of how a drug-specific recommendation looks:

Individual recommendation regarding the applicability of the biowaiver procedure.

3

This is an already prepared recommendation based on my personal work. You just need to enter the required International Nonproprietary Name (INN), and if an individual recommendation for this INN already exists, you can pay for the document (cost: 30,000 RUB), and the ready solution will be sent to your email immediately.

If the drug-specific recommendation you're interested in is not available, you can submit a request for the search and justification of a comparison drug, starting from 70,000 RUB.

​Пример как выглядит препарат-специфичная рекомендация:

Якорь Решение 3

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.

bottom of page