Streamlining Risk Evaluation and Mitigation Strategies (REMS) Submissions

Fortune 500 healthcare company improves time-to-market by applying process improvement to regulatory submissions

To ensure that our client’s new process holds up in real-world situations, we developed it while helping them implement one of their largest and most complex submission projects.

Overview

When a Fortune 500 healthcare company faced delays and escalating costs in their submission process for Risk Evaluation and Mitigation Strategies (REMS), they contacted Primitive Logic.

The Challenge

Since 2007, the FDA has required pharmaceutical companies to conduct REMS to ensure that the benefits of certain drugs outweigh their risks.

Our client was dealing with the side effects of an inefficient, slow, and costly REMS submission process. Process documentation was outdated and difficult to follow, and each new submission required starting from scratch, hampering the team’s productivity. As a result, submission projects often ran behind schedule and over budget.

Cost overruns were cutting into the company’s profit margins, and they faced pressure from competitors to accelerate their time-to-market. The faster our client could get their REMS submissions into the FDA’s hands, the more likely they were to outpace the competition in delivering new drugs to the marketplace.

Why They Chose Primitive Logic

Primitive Logic’s relationship with this client had spanned more than 10 years and encompassed successful completion of more than 30 projects. Our client recognized this project as an opportunity to expand on our previous work and to maximize the benefit from their investments. The company was also facing a tight timeline due to internal pressures and budget overruns, and they knew that our knowledge of their business and our deep experience in process improvement would enable us to deliver results quickly.

The Results

Primitive Logic first met with the REMS team and other stakeholders to review their current processes and to identify gaps. We then aligned existing the documentation with FDA standards and best practices, in addition to developing

  • New processes and work instructions to fill gaps
  • Reusable templates for submission deliverables
  • An end-to-end process map covering work across multiple facilities and highlighting dependencies at each stage
  • A new database and reporting application with cleansed, accurate data

Upon completion of the project, we developed and executed a communication plan to introduce the new processes, templates, and reports to all stakeholders and to gain buy-in across the organization.

To ensure that our client’s new REMS submission methodology holds up in real-world situations, we developed it while helping them implement one of their largest and most complex submission projects. We had the opportunity to prove the effectiveness of the approach as we were creating it, and by the time the project finished, our client had evidence that their new submissions process would deliver the time and cost savings they needed.

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