Business Change Case Studies

An Innovative Pharmaceutical Operating Model Change

Project Overview

Project Overview

Our global pharmaceutical client has has committed substantial resources to ensure the governance and standardization that regulatory authorities require from Pharmacovigilance and Quality maintains consistency on a worldwide scale. Part of this investment was the creation and deployment of an innovative pharmaceutical operating model change which aimed to provide affiliates from across the globe with a systematic framework to operate within.

We collaborated with our client to design the new operating model, define the required workstreams, and develop and deploy a comprehensive communications and engagement approach – uniting the clients’ stakeholders, change teams, communications teams and external vendors – to effectively communicate and execute the change to over 100,000 end users in 90+ countries across the world.

Our Methodology

Our Methodology

This pharmaceutical operating model change required careful construction of systems that could adapt to local needs while maintaining global integrity. To achieve this, we partnered with business sponsors and stakeholders, spearheading the development of:

  • A compelling transformation narrative and associated key message architecture which led to an engagement presentation for key stakeholders.
  • A guidebook to help stakeholders deploy the program containing data, intelligence which we collected and analyzed, plus direction for the user.
  • Leadership resistance and resilience training and mentoring.
  • A centralized portal to communicate the program narrative and serve as the hub for all stakeholders to engage with the initiative. The portal included customized content available for each region and role.
  • The coordination of multiple in-person engagement events and virtual showcases including the preparation and development of materials to deliver the vision of the program.
  • Leadership examples and ‘success story’ case studies to encourage adoption across the broader organization and bring the program to life. The deployment of best practices using videos and articles to bring this to life.
  • A central HR toolkit which was later developed into regional toolkits to reflect the local HR requirements and reporting processes.
The Impact We Delivered

The Impact We Delivered

This transformation represents more than process optimization – it’s a narrative of pharmaceutical excellence where teams learned to harness standardization and compliance as competitive advantages in serving patients worldwide.

  • The program narrative and key message framework has provided structure and consistency and continues to evolve and provide authentic messaging for further rollouts of the program.
  • Thanks to the engaging and targeted content, the centralized portal quickly became one of our clients’ most successful project portals ever, with over 1,000 unique visitors from 42 different countries
  • We produced over ten items of content for the portal every month including: announcements, success stories, news articles, videos.
  • We facilitated a number of live events which were highly successful in engaging with key stakeholders. The events’ impact were further reinforced by post-event materials such as videos, photos and private portal areas.
  • Best practice has now been established following the ‘success story’ case studies. This is being used to guide and inform the business as it rolls out the program to new regions.

By developing internal capabilities and fostering a culture of regulatory innovation, this pharmaceutical corporation transformed their operating model change from a complex compliance challenge into a powerful engine for global standardization – creating sustainable frameworks that turned regulatory oversight from a fragmented burden into a unified commitment to patient safety while building the adaptive infrastructure necessary for continued pharmaceutical excellence across diverse markets.

Find out more about how our life sciences consulting can help you make your change stick

Get in touch!
If you'd like to discuss your change with one of our specialists, email enquiries@afiniti.co.uk.

To get the latest change tips, advice and guidance directly to your inbox, sign up to our monthly Business Change Digest.

Related Case Studies

© 2026 Afiniti