Regulatory support

Globe Medical provides services for obtaining all possible documents, which are necessary for conducting of Clinical Trials.

In accordance with requirements of local legislation, Globe Medical prepare documents for issue approvals for importation/exportation of medicines for Clinical Trials and NPP, biosamples, laboratory kits, equipment, reference samples and reagents for quality control and registration.

In accordance with requirements of local legislation, Globe Medical prepare documents for issue approvals for importation/exportation of medicines for Clinical Trials and NPP, biosamples, laboratory kits, equipment, reference samples and reagents for quality control and registration.

Globe Medical warrants to receive an import/export license withinin 10 days.

Getting approvals:

  1. MOH importation/exportation of Study Drugs;
  2. MOH importation of unregisterd drugs under NPP (program);
  3. MOH importation/exportation of biosamples under Clinical Trials;
  4. MOH reference standards for pre-clinical studies;
  5. Roszdravnadzor importation of reference standards for quality control and registration;
  6. Roszdravnadzor importation/exportation of physician biosamples;
  7. Federal Security Service importation of equipment;
  8. Certificates of compliance for the importation of laboratory kits, electronic equipment;
  9. Declarations of conformity for registered products;
  10. Test reports, expert conclusions.

* "Roszdravnadzor" - The (Russian) Federal Service for Supervision in the Sphere of Public Health Services.