1 Start-up activities: Supporting with preparation and submission of Clinical Trials:
  • Reviewing general and Clinical Trial documents;
  • Consulting for clinical trials process, workflow and documents;
  • Supporting with preparation of documents set for Clinical trial reviewing approvals;
  • Submission documents for reviewing and approvals of clinical trials to Ministry of Health of Ukraine;
  • Reviewing and supporting documents for import and export licences for trials materials.


2 Obtaining of permits and Export Licences for bio-samples exporting to central laboratories:
  • Analytics and calculation of samples quantities for exporting;
  • Analytics and preparation of analysis/vials list for exporting;
  • Setting us process of export of biological samples;
  • Organization of biological samples exporting to central laboratories and preparation of relative customs documents for clearance of samples out for export. Collaboration with couriers companies for export and online control of customs documents availability.


3 Obtaining of Import Permits and Import Licences for importing of study drugs and clinical trial materials (Laboratory kits, study equipment, etc.) from following Regulatory Affairs:
  • Obtaining of Import Licences from State Expert Centre of Ministry of Health of Ukraine (Pharmacology center);
  • Obtaining of Import Permits from State Service of Drugs MOH for importing of medical goods (like Laboratory kits, medical study equipment, etc);
  • Obtaining of drugs-confirmation-letters from Pharmacology Development Department MOH for importing of drugs and immunobilogy (antibody) drugs;
  • Ukrainian Radio Frequency Committee - Obtaining of Import Permits for importing of study laptops, e-diaries, etc.;
  • Ukrainian State Metrology and certification centre (UkrCEPRO) – obtaining of metrology import permits, organization of metrology attestation that is obligatory or by request. Obtaining of letters/ permits re certification procedure;
  • Security Service of Ukraine – Obtaining of Import Permits for importing of study laptops, e-diaries, etc.;
  • Chamber of Commerce of Ukraine.


4 Verifying of medical product’s (study drugs) labels according Ukrainian laws and customs rules:
  • Labels reviewing;
  • Providing recommendations according Ukrainian laws and customs rules.


5 Handling and managing of communication regarding organization of import/export process directly with sponsors and shippers for each shipment:
  • Our company has good experience mailings and communications directly with clients and shippers (in Ukrainian, Russian and English) regarding each of supply for preliminary agreeing shipping details, tracking of shipments nd forwarding;
  • Verifying of cargo documents and providing recommendations concerning right completing and corrections if needs;
  • Setting up the logistics process;
  • Organization of supply process with coordination couriers & customs brokers companies and customs posts taking in consideration day-by-day law & customs situation for simplifying and expediting of import completion & clearance through customs.


6 Organization of delivering of a shipments:
  • Kiev and Ukraine;
  • Cooling shipments;
  • Preparation of cargo documents;
  • Tracking of shipments;
  • Reporting for each of supply, site and study;
  • Informing of customers.


7 Organization of clearance of shipment through customs:
  • Preparation of paperwork for clearance;
  • Coordination of clearance process with customs brokers;
  • Organization of clearance for Import and Export;
  • Keeping the client informed for the process status;
  • Customs duties pass-through payments.


8 Collection of clinical trial material at warehouse after clinical trial completion:
  • Preparation of returning documents that proves receiving materials from sites;
  • Recalculation and registration of returning materials;
  • Materials packaging and preparation for returning to customer/vendors;
  • Reporting to customers for the collected materials;
  • Export of collected materials;
  • Delivering of the materials to customs post for clearance and shipping;
  • Organizing of local destruction materials by request.


9 Warehouses services for shipments storing and handling:
  • Ambient, cooling and frozen shipments;
  • Long in and log out of each supply;
  • Customers reporting for shipment status of each of supply;
  • Automatic forwarding of shipments and/ or by individual requested;
  • Safe-storing of supplies and.


10 Preparation of shipment’s cover letters as “act of transference/acceptance”:
  • Preparation of shipment’s “act of transference/acceptance”;
  • Control of receiving the documents by all parties sites and customers;
  • Control of rightness filling in;
  • Control and duplication of missed / lost documents.


11 Local purchasing of materials for clinical trials:
  • Mailings and negotiations with customers;
  • Budgets settings;
  • Terms settings;
  • Marker review for prices and availabilities;
  • Supplying according agreed terms to sites;
  • Payments flexibility.


12 Rental of materials for clinical trials:
  • Mailings and negotiations with customers;
  • Budgets settings;
  • Terms settings;
  • Supplying according agreed terms to sites;
  • Payments flexibility.