RUSSIA BELARUS UKRAINE KAZAKHSTAN Overview of Service Capabilities VORTEX • Founded Founded2005 2005- Private - Private Management Owned andand Management Owned •• 54 Years YearsofofGrowth Growth and Success and Success •• Extremely ExtremelyHigh High Level of Client Retention Level of Client Retention •• Own 600 Employees Distribution Centre • Regional Specialised Call Centers VORTEX DEPOT RUSSIA - Moscow USA: 375 Europe & Asia: 125 VORTEX DEPOT BELARUS- Minsk VORTEX DEPOT UKRAINE - Kiev • Corporate Solutions Team VORTEX DEPOT KAZAKHSTAN- Astana USA, Europe & Asia: 100 • Corporate Solutions Team • 4,000 + Global Service Partners Global Service Partners • 24 x 7 x 365 About VORTEX… • VORTEX is a specialized Distribution Center which successfully conducts business on the territory of the Russian Federation and abroad. • We are devoted to our customers and offer them high level of quality and reliability in services in the sphere of the Clinical Trials. • Our High-Qualified Personnel provides effective activities on the most difficult areas of CIS. VORTEX: - Delivering innovative solutions - Industry Intelligence - And complete peace of mind Areas of Focus … VORTEX Services VORTEX Services PROCESSING and DEVELOPING Importation/Exportation •All Essential Medication, Materials and Equipment (Study Drug, Vaccines, Laboratory Kits, CRF’s, All Medical Equipment, etc.) •Own Customs Broker Activity •Coordination Of Dispatch, Invoice Approval and Management Of Customs Clearance Processes •Timelines do not exceed 3 working days Receipt, Checking and Stock-Tracking •Active Troubleshooting System •Next Day Readiness to Dispatch •Full-Time Inventory Storage and Facilities •Temperature and Humidity Control with Strict Automatic Management System •Warehouse Designed and Equipped for Separate Storage of Different Study Materials •Validation Facilities / Chambers for Special Packaging Solutions +15 … +25°C / +2 … +8°C / -20 ± 5°C / -70 ± 5°C / -86°C VORTEX Services Re-Labeling Process •Validated Premises / Chambers •Experienced Staff Distribution / Return / Recall / Transfer Process •Own Courier Company operating on the territory of Russia, Ukraine, Belarus and Kazakhstan •Close Contact With Investigator Sites located in Russia, Ukraine, Belarus and Kazakhstan •Service Trials With Strict Temperature Control +15 … +25°C / +2 … +8°C / -20 ± 5°C / -70± 5°C / -86°C VORTEX Services Cold Chain Capabilities… • VORTEX is able to provide packaging and key supplies on a global basis • Work with suppliers that have global manufacturing capabilities, particularly in the emerging markets - Regional or local climate specific shipping systems • All packing materials are fully validated and have pack-out instruction diagrams • Validated / Testing Rooms and Cooling Chambers for special packaging • +15 … +25°C / +2 … +8°C / -20 ± 5°C Shippers with Summer, Winter and Year round profiles. Dry Ice units, ambient systems and validated controlled temperature products • Validated and Calibration Temperature logging devices: Available for ambient, refrigerated and frozen shipments, ranging from simple visual systems to detailed logging VORTEX Services • Destruction Process Contract With Certificated Destruction Company Compliance With Regional Legislation Provide All Necessary Documentations Complete Cycle… PRE-STUDY ACTIVITY STUDY SET-UP DESTRUCTION IMPORT EXPORT VORTEX DISTRIBUTION CENTRE RETURN/RECALL/ TRANSFERE RECEIVING /CHECKING DISTRIBUTION STORAGE RELABELING Quality Assurance Overview… Experience Customer centric internal & external measurements • SOP’s to Ensure Maximum Efficiency & Quality Staff Quality Control System Quick’s commitment & investment to quality driven service • Quality Control Manual Complete Cycle Communications • Disaster Recovery Plan Communications NEW STUDY ELABORATING WITH CUSTOMER WORKING OUT WITH BROKER STAFF FAMILIRIZATION DEVELOPING WITH INVESTIGATORS INICIATION WITH CRO TEST DELIVERES EQUIPMENT CALIBRATION/ FACILITIES SPECIFICATION STAFF TRAINING VORTEX Staff…