BPM in Regulatory Affairs Process

BPM in Regulatory Affairs Process

The regulatory affairs (RA) and registration management processes, like any other business process, has all the attributes that merit good systems of planning, automation, monitoring and process improvement and, thus, the application of Business Process Management (BPM) methods. Even more, due to the wide variety of regulatory requirements configurations applicable in order to obtain and manage licenses registrations during their life cycle, the end-to-end process exhibits the qualities of a made-to-order supply chain model. Thus, a RA process is, part standard operations process and custom project management.

As such, there are many best practices developed in various industries that fit well in an RA operation. Unfortunately, some of these realities are simply missed by many organizations who manage RA activities as an after-the-fact transaction.

This is why an RA Operation needs to be looked through the eyes of BPM in order to achieve efficiency and predictability. The resources in RA are often sought to have deep knowledge in local regulations and government requirements. However, an RA operation that applies the various elements of BPM needs resources that understand planning and capacity utilization, budgeting, project management, KPI and process improvement methods, systems development, and automation, in addition to the technical regulation experts. Making this change in the way we look at, and staff RA will dramatically transform the culture and the business value add proposition of the function.

Allow me to share a real-life example. Our client, a prominent Fortune 500 organization, needed to support a portfolio of strategic, large scale project with impact in product registered around the globe. With tens of initiatives, thousands of product and tens of thousands of SKUs, managing the scale of this workload without BPM would put at risk the client’s ability to maintain its product portfolio in all impacted countries.

Here are the systems put in place to allow this operation to successfully manage the challenge and meet the projects deadlines:

  1. process workflow design and digitalization using Microsoft cloud-based solutions
  2. creation of workcenters, standard effort times and a capacity management tools
  3. a project activity scheduling system based on standard cycle times
  4. project status dashboards and alarms to facilitate tracking a follow up
  5. a structure comprised of planning, execution, and submission teams
  6. project-based budgeting templates

BPM methods and tools pose a great opportunity to make RC a strategic operation. Companies need to look at how BPM can help them transform their RA operation. The result is an efficient RA operation that will no longer be view as an unavoidable cost of doing business, but rather an indispensable and strategic link in the supply chain that helps increase profitability, improve speed-to-market and protect the company brands in the markets worldwide.

Alexander Peña, PMP, SSBB, MBA
Partner and Lead Consultant

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