Case Study - Eliminating Delays: TrainingPros Transforms Regulatory Efficiency with a Pharmaceutical Client
Executive Summary
TrainingPros’ pharmaceutical client faced significant challenges in completing new drug applications efficiently. Delays in regulatory submissions were costing the company billions in lost revenue. Following a company-wide reorganization of its regulatory affairs group, TrainingPros partnered with the internal Learning & Development function to design and implement a structured onboarding and team launch process. This initiative led to a 20% increase in early submissions, zero missed deadlines, and a complete elimination of lost revenue due to late regulatory filings. Over time, the program was scaled across the entire business, reinforcing its long-term impact.
The Challenge
Prior to the reorganization, the pharmaceutical company’s regulatory affairs group struggled with inefficiencies that caused costly delays in drug submissions. These inefficiencies stemmed from:
- Unclear roles and responsibilities.
- Ambiguous decision-making authority.
- Unstructured reporting relationships within and across teams.
- Submission delays ranging from weeks to months, depending on the drug and team.
With every day of delay costing the company up to $800,000 in lost prescription drug sales, the organization sought a transformative solution. While reorganization was necessary, leadership recognized that structural changes alone wouldn’t drive success without addressing the behavioral and operational shifts required to make the new model effective.
The Solution
TrainingPros collaborated with the internal Learning & Development team to design, develop, and deliver a global team onboarding and launch program tailored to the newly structured regulatory affairs function. The key components of this program included:
- A one-day team launch workshop was conducted at the annual face-to-face regulatory affairs meeting.
- Guided exercises to help teams establish their mission, operating norms, and behavioral expectations.
- A structured framework for teams to develop roadmaps to align work with business objectives.
- Instructional design and facilitation support to ensure the program’s effective delivery.
- Skill-building for internal teams to maintain and scale the initiative post-rollout.
This structured approach helped teams navigate their new roles, align priorities, and streamline regulatory submission processes to reduce costly delays.
The Result
The onboarding and team launch initiative drove measurable success:
- Zero missed deadlines in regulatory submissions post-implementation.
- 20% increase in early submissions, accelerating drug approval timelines.
- Billions of dollars recovered by eliminating revenue loss from submission delays.
- The program was adopted enterprise-wide, reinforcing a culture of operational efficiency across the company.
By integrating structured onboarding with team development, TrainingPros helped transform the pharmaceutical company’s regulatory operations into a streamlined, high-performing function.
Conclusion
When structural changes alone aren’t enough, investing in team alignment and onboarding can be the key to unlocking performance gains. TrainingPros’ expertise in instructional design and team facilitation enabled this pharmaceutical company to turn a costly problem into a competitive advantage.
Resources Provided
- Instructional Design Consultants
- Facilitators
- OD Consultant
Technology Used
7 Key Design Elements of Successful Onboarding Programs
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