Pilgrim Eases Regulatory Submissions Process
Pilgrim Software, a provider of Enterprise Compliance and Quality Management (ECQM) software solutions, announced a strategic partnership with Virtify, a producer of web-based software solutions for the Life Sciences industry. Together, they will provide an Electronic Regulatory Submissions solution to reduce the complexities and accelerate the submissions process lifecycle.Pilgrim and Virtify aim to support the enterprises’ submissions efforts with a solution that enables electronic submissions to speed up manufacturers’ product approvals and time to market. The joint offering is based on Microsoft .NET and XML technology. Pilgrim’s SmartDoc document management solution is integrated with Virtify’s Virtx eCTD platform. The Virtx Electronic Common Technical Document (eCTD) product is a solution that enables organizations to: * Collaborate in a web-based environment * Create, view and manage eCTD submissions * Store re-usable submissions information Pilgrim recognizes the growing complexities of the regulatory submissions process. Even now, many companies are still using manual, paper-based processes, “even though the era of mandatory electronic filing is upon us,” according to Nikki Willett, VP of marketing and regulatory affairs at Pilgrim Software. The Regulatory Submissions solution provides all the elements needed for eCTD or non-eCTD electronic submissions (NEES), and will help organizations prepare for the global mandates by regulatory agencies. Using this offering from Pilgrim and Virtify, companies will gain complete control over the submission document lifecycle: from streamlining submission planning, preparation and tracking to high-quality and seamless assembly and publishing. The web-based automated product also ensures improved quality control and timely distribution.