Redesigning the Regulatory Submissions Process

The internal consulting group at a Fortune 200 pharmaceutical company was redesigning the organization’s regulatory submission process—and creating an integrated framework to use for planning all submissions. The group had already installed a technology solution to facilitate communication between the company’s headquarters and its individual areas and affiliates. Yet they lacked the process assessment expertise that they needed to align around a single, streamlined global approach. The head of regulatory affairs turned to Business Talent Group (BTG).

BTG delivered an experienced pharmaceutical manufacturing and regulatory consultant who had previously worked at IBM and A.T. Kearney—and had deep program management, change management, and business process transformation expertise. Over the course of the six-month project, this consultant worked with stakeholders to create a comprehensive, universal submission process. He also developed a detailed change management and training plan and built a governance and operating model for the new solution. Deliverables included detailed future-state Integrated Business Planning (IBP) process maps.

Value: Experienced business process transformation support, tailored to the needs of a global regulatory organization

About the Author

Leah Hoffmann

Leah Hoffmann is BTG's Content Strategist. A former journalist, Leah worked for Forbes.com and The Economist before joining BTG. She is passionate about clear thinking, sharp writing, and strong points of view.

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