Health Canada E-Review Program Uses GlobalSubmit to Support Their Validation Process

PHILADELPHIA, June 24 /PRNewswire/ -- Health Canada, as well as all regulatory authorities who receive electronic Common Technical Document (eCTD) submissions for human therapeutics, is reporting problems with lack of compliance with the electronic format. The lack of compliance is making it difficult to conduct electronic reviews.  Health Canada's electronic submission review (E-Review) program is committed to increase compliance in electronic drug submissions and improve the ability to conduct effective reviews. GlobalSubmit's products will help fulfill their mission especially with respect to study tagging file (STF).

The lack of compliance has not stopped Health Canada from making tremendous progress in their E-Review program.  The E-Review program achievements include: implementation of a Records Documents and Information Management System for Drug Master File (DMF); establishment of business process for receipt, validation, processing & storage of eCTDs; and initiation of a pilot providing remote users (e.g. teleworkers and external reviewers) access to electronic submissions via Citrix Web Office and update of guidance documents.

Health Canada has purchased a one year subscriptions of GlobalSubmit REVIEW™ and VALIDATE™ to increase compliance with their E-Review program.

Rahul Mistry, CEO of GlobalSubmit, states, "GlobalSubmit is helping Health Canada improve their E-review program. Health Canada will see immediate differences in the ability to validate electronic submissions, therefore improving their ability to conduct effective review and we look forward in helping to bring electronic submission to therapeutic areas beyond human pharmaceutics."

About GlobalSubmit

GlobalSubmit is a products and services company that provides transparency in regulated healthcare products. Health Canada, the U.S. Food & Drug Administration and leading Life Sciences companies use our flagship software applications, REVIEW™ and VALIDATE™, to review and validate electronic submissions. GlobalSubmit's thought leaders lead international standards efforts, constantly working with the industry and with government agencies to standardize product and study information. The company is headquartered in Philadelphia, Pennsylvania.

SOURCE Global Submit, Inc.