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Main  >  Services  >  Localization of pharmaceutical manufacruting in Russia, Europe, Asia and Latin America

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»

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

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