Optimizing Regulatory Information Management

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Optimizing Regulatory information management (RIM) is something every pharmaceutical company must plan for. Defining RIM can be a challenge, however, since there’s no ICH standard for what should be done. But right now your organization is dealing with the reality of managing several drug submissions weekly for multiple medicinal products. That includes keeping track of the regulatory activities associated with these submissions, attempting to manage agency commitments, and organizing and sharing the daily updates of agency correspondence. Without a central hub to capture critical regulatory data and turn that data into actionable intelligence, your business is at risk of missed deadlines, delayed market approval, and non-compliance.

Is Your Company Optimizing Regulatory Information Management?

Does your organization have the right ecosystem in place that leverages cloud-based technology to manage RIM and eCTD data for your product families? Is technology or regulatory services the answer? Perhaps it’s a combination?

No longer sensible, nor able to pass ROI analysis, are the monolith solutions that were built for a few select Tier 1 pharma companies in the past. Instead, a scalable, web-based RIM approach that utilizes continuous delivery and cross-solution interoperability is what modern technology can now offer.

Once considered a solution ‘in the future,’ we are now seeing RIM solutions that can be deployed for Tier 1 through 3 companies. Synchrogenix has proudly released their foray into the industry with GlobalSubmit RIM, initially consisting of GlobalSubmit MANAGE and GlobalSubmit COMMUNICATE, and integrated with GlobalSubmit REVIEW.

GlobalSubmit RIM addresses industry costs like software validation, implementation, and maintenance upgrades. Feature enhancements are through Cloud deployment providing an almost immediate ROI. Scalability is offered through an interoperable yet decoupled approach for product seats. Visibility and access is provided for all team members in the same system — no more spreadsheets and documents with conflicting information. Both RIM technology and global regulatory services are tethered together like never before in the Synchrogenix ecosystem for life-sciences.

Gone are the days when your company was left to choose between two options — costly, overly complex systems and homegrown mash-ups. You can begin optimizing Regulatory information management today and create harmonization within your regulatory affairs department.

To learn more about Synchrogenix’s GlobalSubmit RIM solutions:

Author: Rob Connelly

Rob Connelly, Senior Director, Product Management, brings a wealth of experience in regulatory operations and electronic publishing to Synchrogenix, a Certara company, having developed a variety of internal systems and overseen the submission of marketing applications to several countries during his nearly 20 years in the life science industry.

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