Regapharm - Localization of pharmaceutical manufacruting in Russia, Europe, Asia and Latin America

We improve the competitiveness of your business not only at the Russian market, but in the international field too

We help foreign companies to localize pharmaceutical production in Russia. Thus, you will be able to produce your pharmaceutical products in Russia, using all the advantages of local production to conquer not only the commercial segment but also the Reimbursement and the hospital ones.
We help Russian international companies to localize pharmaceutical production in Europe, Asia and Latin America. Thus, you can produce your medicines in these countries, using all the advantages of local production to conquer the market.
We will give you a full consultation on localization of pharmaceutical production and thus avoiding a lot of mistakes, saving your time and investments. Our experts have carried out many similar projects in different countries and are ready to share their experience and success with you.

"Regapharm" offers you a comprehensive approach and effective solution of the problem of registration of drugs

Localization of pharmaceutical manufacruting is conducted in several stages

Selection of the country for localization of production.
Analysis of the market and competitive environment in the country.
Analysis of relevant legislation and prospects for further development for local production.
Selection of the most promising region of the given country for the localization of pharmaceutical production.
Product portfolio formation
Development of technical task (URS)
Choose of project company (development of sketch and basic project)
Preparation and reaching agreement on projection work
Development of sketch and basic project
Expertise of a project (qualificative) by independent organizations
Contest for choosing general construction company
Getting approval for construction on "0" cycle
Development of detailed project
Official approval of the project
Choosing and ordering equipment
Making construction work (concrete skeleton), including clear places, ventilation and all communications, installation of basic and additional equipment
Making production equipment and FAT procedure
Equipment installation
Qualification of equipment (IQ)
Training for personnel
Qualification and validation procedures for checking equipment and technological processes (OQ)
Development of documentation (SOP)
Manufacturing Licensing certification
GMP inspection
Development of validation batches
Checking of stability
Registration of drugs
Start of production

List of documents required for registration of API

List of documents required for obtaining Russian GMP certificate by a foreign producer

Federal Law от 12.04.2010 № 61-ФЗ «Drug circulation»

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