SDL Announces General Availability of SDL Multilingual Submission Management
Solution Developed Specifically for Global Multilingual Regulatory Submissions
SDL (LSE: SDL) has announced the availability of SDL Multilingual Submission Management (MSM), a web-based platform that enables biopharmaceutical firms to globally automate the submission of multilingual marketing authorization applications to regulatory authorities across 100+ languages and markets.
Operating in one of the most demanding and highly regulated environments, pharmaceutical organizations face the constant challenge of filing, updating and maintaining medicinal product information globally. High standards demanded by local regulatory agencies during the submissions process – which varies by country – puts enormous pressure on firms to ensure every element of their application is flawless. Formatting and translation errors can delay timelines by weeks or even months.
SDL MSM enables these organizations to overcome all the multilingual challenges associated with regulatory labelling and submission, providing the industry’s first dedicated platform for centrally managing this process globally. Based on market validated technologies that have helped many pharmaceutical organizations manage their global regulatory labelling submissions for the past decade, SDL MSM also combines a rich set of features that make it simple to manage the complete submission process from a single dashboard.
“Submitting local language documents for regulatory approval with one regulatory agency is difficult enough – let alone across dozens of countries where documents need to be translated, reformatted, and orchestrated in a timely fashion,” said Kaarin Gordon, SVP of global life sciences, SDL. “Our proven success in this area for the past decade – combined with the exciting new web-based features that SDL MSM offers – make it a powerful platform to overcome one of the biggest burdens for international regulatory affairs departments.”
Announced at the Global Pharmaceutical Regulatory Affairs Summit, Prague, SDL MSM offers easier, faster and lower cost deployment – with greater availability of services.