Phlexglobal Releases PhlexRIM 2.0

Phlexglobal Announces Industry’s First RIM Software with Intelligent Business Process Automation to Increase Efficiency and Drive Globally Standardized Compliance

New PhlexRIM 2.0 provides end-to-end regulatory information management, preconfigured automations built around regulatory best practices, and flexibility to map easily to internal processes

Amersham, UK; Malvern, PA. — October 26, 2021

Phlexglobal, a leading innovative technology and services provider for the life sciences industry, today announced the general availability of PhlexRIM 2.0 - advanced, end-to-end regulatory information management (RIM) software incorporating the industry’s first regulatory business process automation capability. The software enables biopharmaceutical companies to define, standardize, and apply regulatory processes consistently across their global organizations, with less time and effort.

PhlexRIM 2.0 offers companies a library of pre-configured automation assistants, or “bots,” as well as built-in regulatory use cases based on industry best practices. Utilizing an intuitive drag-and-drop business process automation design tool seamlessly incorporated with the software’s proven capabilities to manage regulatory content across the product lifecycle, regulatory teams can automate their regulatory processes without programming knowledge or IT support.

With PhlexRIM 2.0, regulatory teams can apply their expertise to:

  • Define, improve, standardize, and implement regulatory processes consistently across their organization, increasing regulatory efficiency and data quality

  • Quickly develop and disseminate new or updated regulatory processes, whether driven by new health authority requirements or improvements in internal procedures, improving the ability to adapt to new requirements

  • Improve the speed, consistency, and accuracy of regulatory activity such as submissions and registration tracking across all countries and regions by replacing manual processes with process automation based on regulatory events, milestones, or other defined triggers

  • Streamline collaboration and communication with health authorities and internal stakeholders


PhlexRIM 2.0 enables regulatory teams to rapidly build, configure, and automate compliance processes with an intuitive drag-and-drop lifecycle editor, leveraging the pre-built best practices library or starting from scratch - without programming.

“Over the past five years, there has been a big push to modernize RIM base capabilities to improve global operating efficiency, product speed, and compliance risk profiles,” noted Steve Gens, Managing Partner, Gens & Associates. “As regulatory shifts to a more ‘data centric’ model driven by structure data submissions and enterprise data connectivity, the opportunities for process automation, data mining, and improved regulatory pathways are significant and a core part of our RIM 2025 potential.”

Additional sophisticated automation capabilities incorporated into PhlexRIM 2.0 further reduce the burden on regulatory teams. Organizations can easily set up and automate master regulatory business processes incorporating subprocesses, for example global processes incorporating national authority requirements; configure conditional automation when specified requirements are met, such as when certain responses are received from a health authority; automatically create and assign regulatory tasks based on pre-set “triggers”; and enable automated processes for affiliate engagement.

“Leading organizations worldwide already trust their critical regulatory information management processes to Phlexglobal, ranging from submission planning and tracking to managing Health Authority communications,” said John McNeill, CEO of Phlexglobal. “With this new release of PhlexRIM software, our customers can now leverage our expertise as well as another first-to-market Phlexglobal technology to streamline and improve their regulatory compliance.”


Best Practices for RIM Business Process AutomationBest Practice for RIM Business Process Automation

Download our guide to obtain pragmatic and proven guidelines for implementing regulatory business process automation to help define, improve, standardize, and implement regulatory processes consistently across your organization

Discover how to increase regulatory efficiency and data quality by:

  • Exploring the benefits achieved by replacing manual processes with automated regulatory workflows and lifecycles
  • Examining a detailed roadmap for making the transition from document-driven processes to a structured data lifecycle
  • Understanding the critical factors that contribute to successful implementation of regulatory business process automation


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