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ISSI STRATEGY

ISSI STRATEGY. CLINICAL RESEARCH : STORAGE AND DISTRIBUTION OF MEDICAL PRODUCTS.

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ISSI STRATEGY

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  1. ISSI STRATEGY CLINICAL RESEARCH: STORAGE AND DISTRIBUTION OF MEDICAL PRODUCTS

  2. ISSI-Strategy company was founded at 2001. it is situated in Moscow, not far from the center, in Ryabinovaya street. In 2008 the company’s management made a decision to create a division responsible for transportation, storage and logistics of shipments for clinical trials. For this purpose the part of warehouse has been reorganised and the speсial customs and logistics services firm was created for the needs of clinical materials transportation. The warehouse of our company answers requirements of the international standart ISO 9001:2000. ISSI-Strategy Presentation, 2009

  3. We work in pharmacological business and provides full clinical trials support: customs clearance support of shipments transportation of shipments storage of investigational medical products and study materials on the licensed pharmaceutical warehouse other accompanying servises ISSI-Strategy Presentation, 2009

  4. Services for storage • Receipt of shipments • Processing of the arrived cargo with entering of the data about cargo in the warehouse program • Storage of shipments according to the following temperature modes: • Mode of ambient storage +15/+25 • Mode of cool storage +2/+8 • Mode of low temperature storage -10/-40 ISSI-Strategy Presentation, 2009

  5. We deliver shipments to investigational sites located in more, than 50 cities of the Russian Federation and near abroad. Moscow, St.-Petersburg, Arkhangelsk, Yaroslavl, Smolensk, Ryazan, Syktyvkar, Togliatty, Kazan, N.Novgorod, Voronezh, Obninsk, Ekaterinburg, Rostov-na-Donu, Saratov, Tomsk, Tjumen, Krasnodar, Volgograd, Novosibirsk, Sochi, Kemerovo, Ivanovo, Omsk, Barnaul, Krasnoyarsk, Vladivostok, Ufa, Yakutsk, etc. ISSI-Strategy Presentation, 2009

  6. Capabilities: • A new warehouse • Close co-operation with regulatory authorities and customs • Storage of IMP at controlled ambient and cold temperature regimens • Storage of IMP at controlled humidity conditions • Own patented storage computer program • Re-labeling • Archiving • Qualified staff trained in GCP/GDP ISSI-Strategy Presentation, 2009

  7. Our company focus on: People Customers Quality Continues innovation ISSI-Strategy Presentation, 2009

  8. Our priorities: • Security of sponsor’s IMP at any • respect and at any stage of handling • Professional, GMP and GDP compliant IMP • management • Our ultimate ambition is to become your reliable • partner. ISSI-Strategy Presentation, 2009

  9. Plan of the warehouse • 1.Distribution Zone • 2.Reception Zone • 3.Quarantine Zone • 4.Expired Zone • 5.Damaged Zone • 6.Destruction Zone • 7.Return IMP Zone • 8.Return SM Zone • 9.Labeling Place • 10.WC • 11. Economic room • 12. Operation Office • 13-14. Electrical control unit • 15-17. Unused premises ISSI-Strategy Presentation, 2009

  10. We have a certificate of conformity. This certificate certifies that quality management system complies with the requirements of ISO 9001:2000. Also ISSI-Strategy is franchisor of its own computer program. ISSI-Strategy Presentation, 2009

  11. The license for possibility of realization of pharmaceutical activity ISSI-Strategy Presentation, 2009

  12. ISSI-STRATEGY LLC 123471, Russian Federation, Moscow Ryabinovaya str., 43 build 1 Tel: +7(499) 792 7651 Fax: +7(499) 792 7652 info@issi-strategy.com www.issi-strategy.com Contact Persons: Executive Director: ShvetcAlexey Warehouse pharmacists: ChernetsovaAnastasiya, KvashinaEvgeniya ISSI-Strategy Presentation, 2009

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