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Complex solutions for introducing your products on the markets of Russia, Europe and Asia

We improve the competitiveness of your business not only at the Russian market, but in the international field too
  • Our experts will examine the current rules of pharmaceutical market regulation, which affect your launch.
  • We give you a perspective on the legislative framework development in the field of registration and Clinical Study.
  • We find the risks of launching new drugs and provide matching services.

Analysis of a product portfolio for registration into the Russian Federation

  • We examine Your product sales IMS data versus its competitors in Russia.
  • We predict your sales forecast and the market share for Your product portfolio after registration and over the next 5 years of sales.
  • We offer You competitive pricing with good profit.
  • Taking into account market segment and regulatory changes we evaluate a market attractiveness in the longer term.
  • Based on the above analysis you choose only the  products for registration that will bring you high profit and the ability to develop new markets.

Registration plan development

  • We carry out a primary expert examination of Your Dossier and offer You the optimal and most time-effective registration plan.
  • At this stage we decide what Preclinical and Clinical Studies are requested for registration.
  • At this stage we identify the registration period duration and required resources.

Preclinical and clinical study conduction

  • If You have no Preclinical Studies we design them and present reports in a short time.
  • Then we prepare the documents necessary for obtaining permission for the Clinical Study of a drug and obtain permission for the conduct of a Study.
  • We organize and conduct a Clinical Study for the purposes of drug registration into the Russian Federation or for international multicentral Clinical Study.

Obtaining a Russian GMP certificate

  • We prepare documents for submission to the Ministry of Industry and Trade of the Russian Federation to obtain conclusion on manufacturer conformity (foreign manufacturer) with the Good Manufacturing Practice.
  • Obtaining the Russian GMP certificate is in progress along with the conduct of the Clinical Study or before the Dossier submission to the the Ministry of Health, if Clinical Studies are not requested in a drug registration process.
  • If You are interested in obtaining an EU GMP certificate, we will help You obtain it in Germany, and it will be available for all EU member states.

Obtaining a Registration Certificate

  • We prepare and complete your dossier for submission to the Ministry of Health in accordance with the Federal Law - 61
  • After the MoH internet portal registration and submission of the Registration dossier, an examination of the relationship between the expected benefits and the possible risks of the use of the drug for medical use is carried out.
  • After successful expert examination we obtain Marketing Authorization.

Product launch on the Russian market

  • We help you to generate a business plan for your product.
  • The Marketing plan will help you launch your product into new market successfully.
  • We can consult you on your product launch. You can launch a new product by your means or with your partners.
  • We will help you to use Your medical representative resources most effectively over the vast domain of the Russian Federation.
  • We will conduct an independent examination of your strategy and new market development plan, designed by your staff. It will help you avoid many errors and save time in the beginning of your business after registration.

For the health system development in respect of pharmaceutical regulation in Russia, CIS countries and the Customs Union some changes were adopted.

These changes have had a significant impact on pharmaceutical business development.

The key problem for pharmaceutical companies is working in accordance with requirements of registration, licensing and and conducting of a Clinical Study when launching a new drug into the Market.

Manufacturers and distributors of medical products, and manufacturers and distributors of pharmaceutical products from Russia, CIS countries and Europe working in Russian markets are united by the significant understanding of these changes and the adequate introduction of amendments to everyday life. This fact helps them generate a plan for the effective development of Pharmaceutical business in the new market.

What does the modern Russian pharmaceutical market look like?

Among the supplied products there are obsolete and ineffective substances, drugs with low-efficiency. The import drug segment is very large.

In the market there are many drugs that were commercialized in the 70-80’s. However more and more new modern high technology and high efficiency drugs are developed annually.

A realistic alternative for an export drug is the development of effective drugs at a reasonable price. This idea become one of the most significant problems for local manufacturers in a down economy.

The company “Regapharm” stands for the development and effective launching of drugs, pharmaceutical substances and medical products into the Russian market, and into the European and Asian markets too!

We develop and offer comprehensive solutions for launching into the Russian, European and Asian markets.

“Regapharm” has excellent experience in successfully conducting any phase of a Clinical Study. The company has knowledge and extended experience of document management and helps clients to prepare for complex inspection.

We show new rules and regulatory requirements to pharmaceutical companies and help them to register medicinal products, to complete the service list for this procedure.

Please, phone us and our experts will answer all your questions on registration.

We will be glad to help you with your successful business development!

List of documents required for registration of pharmaceutical products
List of documents required for obtaining Russian GMP certificate by a foreign producer
Federal Law от 12.04.2010 № 61-ФЗ «Drug circulation»

To receive a consultation on drug registration services in Russia, please use the form below.

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