Pharmaceutical companies must navigate complex and ever-evolving regulatory requirements to develop and market therapeutic products. Whether they’re seeking approval for selling a new drug or providing updates to regulatory agencies on long-term use and safety of products, the volume and complexity of submissions continue to grow — all while the Regulatory Affairs departments managing these submissions struggle with limited resources and staffing. The consequences can be staggering: a single day of delay in getting a new product to market can mean the loss of tens of millions in sales.
In order to help Life Sciences companies do more with less and keep pace with the latest regulatory requirements, OpenText is pleased to introduce OpenText™ Core for Regulatory Plans. A SaaS solution built in the OT2 Cloud, the product helps customers plan, execute and manage complex global regulatory submissions.
Key capabilities of OpenText Core for Regulatory Plans
Through a modern user experience, automation and smart process-aware features, this new solution increases efficiency. It helps customers to:
- Minimize the risk of submission delays by improving accuracy via content reuse, automated notifications and automated document assembly
- Speed review cycles with flexible submission review workflows that eliminate the need to retool existing business processes or endure lengthy configurations
- Gain real-time visibility into the status of their global regulatory submissions
Core for Regulatory Plans makes it easy to set up a new submission using a wizard that guides you through the entire creation process. Simply navigate through the eCTD tree and select the nodes needed to define the desired submission content. Appropriate documents can be automatically identified and assigned to your new submission without manually searching and browsing long document lists. Existing content can by leveraged by out-of-the-box integrations to existing cloud and off-cloud document repositories such as OpenText™ Documentum™ for Life Sciences.
Notify team members
Core for Regulatory Plans keeps teams focused on submission priorities with automated task updates and email notifications that help coordinate across clinical, quality and manufacturing groups.
Core for Regulatory Plans ensures global compliance by creating and managing regulatory events across multiple regulatory jurisdictions. It allows users to rapidly identify registrations and applications impacted by a regulatory event. The dashboard provides real-time visibility into submission status by region and provides a global perspective of all regulatory submissions.
Secure access with GxP compliance
Core for Regulatory Plans ensures secure access to authorized users, meeting FDA 21 CFR Part 11 compliance requirements. Continuous new capability delivery and seamless upgrades minimize deployment risks, while allowing users to rapidly respond to changes in global regulatory guidance with best practices that meet GxP compliance.
Interested in learning more about how to better orchestrate the cross-functional activities and reviews required for regulatory submissions? Take a few minutes and discover more about OpenText™ Core for Regulatory Plans.
For even more insight, register here to attend our new webinar showcasing how to replace manual processes and stay on top of your submissions.