Delta Origin LLC is your Key Supply Chain provider while launching new product at the Russian market Public Relations.

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Presentation transcript:

Delta Origin LLC is your Key Supply Chain provider while launching new product at the Russian market Public Relations

Permits and Licensing Application Services Complex approach for getting samples at the right place on time Compliance (!) FCPA, Code of Conduct, Anti- Corruption policies at every step of a process Customs clearance service at all Moscow airports SVO,DME,VKO express-post terminals of TNT, UPS, FedEx, DHL and Russian post; special Moscow science customs terminal (Rosnano) Permits and Licensing Application Services Consulting We are happy to share with you our experience of variety of business tasks connected closely with launching new products in Russia. Don`t hesitate to contact us about any issues you have. Storage facility for samples: +2°С…+8°С e.g. biogenerics, reference stds. -20°С e.g. reference stds. -70°С e.g. sample of cell-bank “Cold-chain” shipments on terms: “door-to-door” using prequalified packaging solutions of leading providers Distribution of certified reference standards with a lead-time of 2 weeks* *such short lead-time can be achieved for individual orders without consolidation (URGENT service)

Distribution of certified reference standards URGENTLY need a help with reference standards, HPLC column, any other material for an expertise? Send us a name of item you are looking for. We will check availability in our product data-base of over 500 vendors and arrange a delivery on terms "door-to-door"

Pharmacopoeia of USA & Europe LEAD-TIME WAS REDUCED BY INDIVIDUAL LOGISTICS SOLUTION NO STOCK CONSOLIDATION APPLICABLE FOR TEMPERATURE SENSITIVE ITEMS AS WELL: +15°С, +5°С, -20°С 2 WEEKS* * an average lead-time for certified reference standards of US Pharmacopoeia and European Pharmacopoeia. Call us for enquiry

Permits and Licensing Application Services Clinical (trials) and pre-clinical (animals) studies 168 total q-ty of permits were achieved within Q3`2011 - present Pharmaceutical expertise (incl. new dossier and ND or ST variations) 213 total q-ty of permits were achieved within 2010 - present Useful Experience § Permit for import reference standards (no longer needed); § Import license for commercial shipments (until 11`2011) § Other paperwork which required for import formalities

“Door-Door” solution with “cold-chain” compliance 1 day 1 day 2 days 2 days Validation of the shipping paper-work (“green light”) 1 day Pre-carriage from the Shipper to the airport of delivery 1 day Export formalities 1 day Airfreight to the destination point up to 2 days (including possible transshipment at a hub point) Customs clearance at the destination with using of e- declaration or pre-declaration 1 day + 1 day Delivery to the customer 2-3 hours (Moscow, morning time) TOTAL: ≤ 7 days* 2-3 hours NOTICE: * temperature monitoring at every step from the very beginning (DOOR of the Shipper) to the final destination (DOOR of the Customer)

Samples classification Samples of finished product (solid and liquid forms); Raw materials samples (reference standards in-house and CRS); Samples of API; Infectious substances class 6.2 (dangerous goods UN2814 affecting people, UN2900 affecting animals); Regulated medical waste and medical waste n.o.s. class 6.2. (UN3291); Nitrogen, refrigerated liquid class 2.2 (UN1977); Dry-ice, carbon dioxide solid class 9 (UN1845) Certified packaging solutions

Customs clearance (brokerage) service at all Moscow airports and express-post terminals NOTICE At the center of this slide placed an image of customs stamp “cargo released” for demonstration purpose only

Validated SOP* with business environment *standard operation procedures PAPERWORK Preliminary checking set of shipping documents => PROTOCOL Handling objections from the Shippers, assisting with explanations => AGREED SET OF SHIPPING DOX “green light” for delivery DELIVERY Tracking of the shipment using IT data-base Notification of customs warehouse about arrival Getting documents on day of arrival at bonded warehouse CUSTOMS CLEARANCE Getting documents with e-signature from the forwarder (no need to collect stamped/ paper version) => safe time* *Agreed process with DHL-express and TNT-express network Customs declaration and release FINAL DESTINATION Released parcel can be delivered to the Consignee based on Way-Bill

TEMPERATURE MONITORING AT EVERY STEP pre-qualified packaging solutions, data-loggers We offer a complete range of solutions for all your temperature controlled packaging requirements and global manufacturing capabilities. Range of products depends on your needs Understanding that you may require pre-qualified robust solutions without having the luxury of the development time, we suggest cost effective and simple to use temperature controlled packaging solutions; Range of passive Vacuum Insulated Panels (VIP); Phase Change Material (PCM) Temperature Controlled Packaging from Minnesota Thermal Science (MTS) adds further strength and credibility to the existing product portfolio; Passive Temperature Protection systems such as thermal blankets, pallet foil and drum tank can meet both “cold-chain” and cost requirements; KryoTrans System developed to meet design criteria or for client-led validation projects

Validated storage facility +2 … +8 °С - 20 °С - 70 °С* Samples of finished product (liquid forms of bio generics and samples for trials) ICH GxP compliance different type of raw materials for laboratory expertise cell-bank and raw materials for pharmaceutical expertise NOTICE: * Storage in a refrigerator with -70°C (no using of dry ice)

You are welcome to participate in a survey “Life Science and Healthcare Logistics trends 2013”. Only 5 questions in total. Your answers will help us to develop best solutions of your needs. To begin please follow the link http://svy.mk/136WDtX

Thank you for your attention! +7 495 669 30 54 (desk) e-mail: info@deltaorigin.com Business Centre "Brent City" 3rd floor 57 Dubininskaya str., bld. 1 115054, Moscow, Russia