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Combines software to provide solution for the regulatory lifespan of a product
April 13, 2016
By: Kristin Brooks
Managing Editor, Contract Pharma
PAREXEL and EMC Corp. have entered into an alliance to offer a Regulatory Information Management (RIM) and Regulatory Content Management solution for the regulatory lifespan of a product. By combining PAREXEL LIQUENT InSight RIM platform and EMC Documentum for Life Sciences software solution suite, the solution aims to allow for strategy and planning, authoring, publishing, submitting, viewing, archiving, and lifecycle management for a product. The offering is available through PAREXEL’s Regulatory Cloud, a life sciences content and RIM solution structured within a dedicated cloud environment. The EMC Documentum for Life Sciences software suite allows companies to manage and share information across nonclinical, clinical, quality and regulatory groups, within a single source for regulated content. The suite leverages industry standards and utilizes configurable, intuitive, and personalized interfaces to help maximize productivity and ensure easy access to information. “A life sciences company must navigate the complex, global and region-specific regulatory landscape to maintain registration and compliance for a product,” said Paul Bidez, Ph.D., vice president and global head of Regulatory Solutions, PAREXEL. “To help solve this challenge for our clients, PAREXEL and EMC brought together our respective industry-leading regulatory information management platform and industry-leading life sciences content management solution suite within PAREXEL’s Regulatory Cloud.” “Industry pressures are prompting biopharmaceutical organizations to adopt new business models, enter new global markets, and expand alliances and partnerships. To achieve these goals, Life Sciences organizations are becoming more strategic in how they manage information,” said Rohit Ghai, president, Enterprise Content Division, EMC. “By partnering with PAREXEL, we’re enabling these organizations to digitally transform and deliver high-quality, safer drugs to market faster and at a lower cost, while meeting regulatory requirements.”
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