Health Canada selects LORENZ docuBridge for eReview
TORONTO, ON: Following a competitive bid process conducted on behalf of Health Canada, LORENZ Newbook was selected to deliver LORENZ's docuBridge solution for their Electronic Review Project. Health Canada joins a growing number of regulatory agencies worldwide who have chosen LORENZ software to support the review and approval of pharmaceutical regulatory submissions. The docuBridge solution allows the preparation, publishing, management and review of electronic submissions for the Life Sciences industry.
"We are especially pleased as a Canadian supplier to win this comprehensive procurement process from Health Canada," says Anthony Villa, Chief Operating Officer of LORENZ Newbook. "docuBridge provides an Off-the-Shelf solution, and we look forward to working with Health Canada to implement it within their environment. In particular, the new standalone eCTD Validator will provide assurance for regulators and industry that submissions meet eCTD filing requirements."
The Electronic Review (eReview) Project was implemented to establish an electronic review environment that will offer electronic support to the receipt and review of therapeutic products submissions that Health Canada has regulatory authority over, as outlined in the Canadian Food and Drugs Act. It will directly impact: Therapeutic Products (TPD); Biologics and Genetic Therapies (BGTD); Veterinary Drugs (VDD); and Natural Health Products (NHPD). The Electronic Review Project in its entirety will provide a complete automated document-based electronic submission solution to manage therapeutic products submission reviews within HPFB that adheres to industry international standards (including ICH) as well as Health Canada standards.
"Health Canada joins Germany, Austria and Slovenia in selecting docuBridge", says Wolfgang Witzel, President & CEO of LORENZ Life Sciences Group. "We are also very proud of our ongoing involvement in the EURS pilot project, where we have hundreds of submissions under our management being reviewed by over 800 trained reviewers. Our industry customers are reaping the benefits of our strong regulatory presence, as evidenced by their high percentage of successful eCTD submissions worldwide."