CHALLENGE
Driven by expiring patents and shrinking drug-development pipelines as new therapies become fewer and more intricate, most life sciences companies need to continually streamline their regulatory submissions process to deliver new products to market faster. They need a robust content repository to manage what can be millions of documents while maintaining compliance with regulatory requirements.
Companies also need the ability to effectively plan, track, maintain, and assemble essential submission-related documentation. This constantly growing collection of controlled documentation is the primary knowledge asset and is the key to the future success of the organization.
TECHNOLOGY SOLUTION
The OpenText Research and Development solution, part of the OpenText for Life Sciences solution suite, enables organizations to manage the creation, review, and approval of regulatory submission documentation. The solution provides predefined taxonomies and business process rules to reduce deployment time and ensure adherence to industry standards while collaborative authoring capabilities improve productivity and streamline review and approval processes.
With the Research and Development solution, users can quickly search and identify submission-ready content across multiple OpenText for Life Sciences solutions such as the OpenText Electronic Trial Master File (eTMF) and OpenText Quality and Manufacturing (Q&M) solutions for more efficient regulatory submission assembly. The foundation of this solution includes the OpenText enterprise content management platform and OpenText D2 for configuration and intuitive user interfaces, implementation, and migration services.
