Named Patient Program

  • Seamless approvals for importation of unregistered drugs;
  • Customs clearance;
  • Full-patient support and direct-to-patient shipments;
  • Full support of related procurement and logistics services;
  • Specialized Courier Services (temperature-controlled delivery to any destination within 1-2 days)
COREXPERT DISCUSS YOUR CUSTOMS AND REGULATORY CHALLENGES WITH OUR COREXPERT: Nikolay Kapustkin Contact Nikolay Kapustkin Customs and Regulatory Manager
Nikolay Kapustkin Contact
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"After climbing a great hill, one only finds that there are many more hills to climb." Nelson Mandela
Greetings, I am Nikolay Kapustkin and I manage the Customs Clearance and Regulatory Department at COREX.

In 2003, I graduated from D. Mendeleev University of Chemical Technology of Russia and am IATA trained in Transportation of Infection and Hazardous Cargos including subdivision 6.2.
Before COREX I worked in a clinical trial logistics pharmaceutical depot, where I gleaned vast industry experience including but not limited to: warehouse management, customs regulation, regulatory activity and quality control. This experience has been beneficial for my role at COREX, where I am provided an environment of creativity, collaboration and freedom to continue my personal and professional development.

Being a specialist in Customs Clearance and Regulatory Affairs gives me the expertise, training and experience to advise and support clients regarding Regulatory Legislation of the Russian Federation. Under the leadership of Managing Director Konstantin Melnikov, I participate in the development of transportation logistics schemes for imports and exports, maintain company procedures , develop customs procedures guidelines and communicate with state authorities. The results of my activities is not only with respect to import and export under specific protocols, but a framework for logistics supply chain timeline development. My aim is to shorten delivery time to an absolute minimum without waste for optimal business performance and services.

If you have any questions concerning customs clearance, Federal Customs Service requirements, or Clinical Trial Imports or Exports, I will be happy to assist you.

Managed Access Program (MAP) enables physicians and patients to access effective medications that are not yet commercially available on the local market. Regulations in the CIS allow patient to access unregistered drugs that are approved outside of the country upon requests made by physicians on behalf of individuals or “named” patients. Such prelaunch access is governed by specific criteria, collection of safety data, and control of the drug distribution.

Being the only registered operator of personal data in our geographies, COREX successfully manages the full cycle of access programs, from import license submission to customs clearance and distribution. Local project managers coordinate the entire process with the sponsoring company, including representatives from medical affairs, pharmaceutical development, regulatory, supply chain, business development and finance departments.

Contact our COREXPERT to learn more about Named Patient Programs supported by COREX!

corex process approach

  • 1 PROCUREMENT OF THE DRUG Exclusive procurement through direct contracts with manufacturers.
  • 2 COLLECTION OF THE DOCUMENTS Collection of prescription data, Local Ethics Committee (LEC) approval and documents submission to the Ministry of Health (MoH).
  • 3 APPROVALS AND IMPORT LICENSES Obtaining necessary permissions for importation of unregistered drugs.
  • 4 CUSTOMS CLEARANCE Expedited customs inspection and release.
  • 5 DIRECT-TO-PATIENT SUPPLY Direct-to-patient shipment and dispatch in appropriate temperature regimes.
COREXPERT DISCUSS YOUR CUSTOMS AND REGULATORY CHALLENGES WITH OUR COREXPERT: Nikolay Kapustkin Contact Nikolay Kapustkin Customs and Regulatory Manager