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GRINDEX
JSC Grindeks je vodilno farmacevtsko podjetje na področju baltskih držav, ki aktivno deluje na globalnih trgih kot družbeno odgovorno podjetje z ogromnim razvojnim potencialom. Glavna področja poslovanja Grindeksa so raziskave, razvoj, proizvodnja in prodaja lastnih blagovnih znamk in aktivnih farmacevtskih sestavin.
Galina Grecenkova, Project Manager
Linda Litina, Head of Regulatory Affairs
Grindeks has started validating an electronic data-management system that should make it the first Latvian company capable of making all of its marketing authorisation applications electronically.
Validating Infotehna’s global regulatory affairs package, known as GLORYA, started on 1 June, and DMS project manager Galina Grecenkova said she expected Grindeks to be in a position to make its first electronic submission later this year.
"Staff training would be the biggest challenge", she added, not only to use the computerised system, but also to accommodate changes to paper-based procedures that had previously involved numerous document stamps with words like "copy" and "confidential".
"Our main aim at this stage is to put all our paper documents into electronic form," Grechenkova said, "and when we have done so, we expect to spend a lot less time with routine tasks." Referring to glowing references from existing system users LEK, PLIVA and RATIOPHARM, she added: "GLORYA should be able to handle every document and every action in compiling and maintaining our dossiers."
Improved quality of submissions
Her colleague, Linda Litina, head of regulatory affairs, also expects the quality of Grindeks' submissions to be improved. Noting that electronic submissions would become mandatory in Europe by 2009, Litina said Grindeks" first electronic application would be for a new product."
"Our submisssion plan is to start with the newest products," she noted, adding that the firm would be busy scanning existing documents so that variations could also be handled electonically as soon as possible. "We cannot afford to waste any time," she said, noting Grindeks' ambitious expansion plans and agency moves towards electronic working.