Regulatory Support

  • Obtaining Import License for Investigational medical product (IMP);
  • Issuing necessary certificates for medical devices and clinical trial materials (CTM);
  • Named Patient Program support;
  • Obtaining Export License for bio-samples;
  • Controlled Drugs importation and handling;
  • Any additional approvals and permissions.
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.

The majority of clinical trial supplies are subject to specialized non-tariff regulations for unregistered investigational drugs, accompanying clinical trial materials and medical devices in which one must obtain obligatory permissions from the relevant governmental authorities. The situation with import/export regulations differs from country to country. For example, Russian authorities require only one license for the entire project; Ukrainian authorities require one license for the study and one for each bulk shipment; in Georgia, depending on the type of goods, the import license may not be required at all. This is where our  local presence and expertise become invaluable.

Continuous experience in working on some very specific imports/exports for clinical trials (cryptographic devices, hazardous materials, bio-samples, controlled drugs, etc) and an intricate system of SOPs allows COREX to avoid potential risks that may arise when issuing a license or preparing a letter of exemption.

We remove the burden of regulatory processes from our customers by offering submission of necessary documents for official approval of a study drug / CTM importation. COREX regulatory managers are always in constant close contact with the regulatory representatives and are well-informed about any upcoming changes in local legislation. COREX team collects all pertinent documents, double-verifies its completeness and accuracy and guarantees approval within 10 working days.

Contact our COREXPERT to learn more about COREX Regulatory Services!

corex process approach

  • 1 REGULATORY FEASIBILITY Gathering trial-related information and product specifications.
  • 2 CONSULTATIONS WITH LOCAL AUTHORITIES Detailed consultations with regulatory representatives and dossier composition negotiations.
  • 3 PREPARATION OF DOCUMENTS Preparation of necessary documents, double-verification of data completeness and accuracy.
  • 4 EXPEDITED SUBMISSIONS Same day submissions to the Ministry Of Health (MoH) or other designated regulatory body.
  • 5 ISSUING NECESSARY APPROVALS Monitoring submission status and just-in-time receipt of the originals.
COREXPERT DISCUSS YOUR CUSTOMS AND REGULATORY CHALLENGES WITH OUR COREXPERT: Nikolay Kapustkin Contact Nikolay Kapustkin Customs and Regulatory Manager