Regulatory submissions: Process-based help for quality management, compliance is on the way
Enterprise compliance and quality management specialist Pilgrim Software is teaming up with Virtify , a vendor of Web-based software solutions for the life sciences industry, for a complete life-cycle management solution surrounding the regulatory submissions process. Pilgrim’s Regulatory Submissions solution sets up electronic submissions to speed manufacturers’ product approvals and time-to-market. The joint offering is based on applications built on Microsoft .NET and XML technology, including Pilgrim’s SmartDoc document management solution integrated with Virtify’s Virtx eCTD platform.
The Regulatory Submissions solution provides all the elements needed for eCTD or non-eCTD electronic submissions (NEES), and will help organizations prepare for global mandates issued by regulatory agencies. Companies reportedly can gain complete control over the submission document life cycle—from streamlining submission planning, preparation, and tracking to seamless assembly and publishing.