Harmonizing a Global Regulatory Submission Process Post-Merger

PROJECT BACKGROUND

Following the merger of two major pharmaceutical companies, the newly formed (merged) organization quickly recognized that the processes for creating, managing, and archiving documents required for regulatory submission varied significantly between the heritage organizations. These variances were exacerbated due to cultural differences and limitations in capabilities observed across its global affiliates. In order for the company to reach its ultimate goal for reducing time to market, several issues needed to be addressed:

  • A common database needed to be developed to store all documents that support regulatory submissions 
  • Each business unit needed to harmonize global processes for creating, managing, archiving, and ultimately compiling submission documents

This objective presented an extraordinary challenge in that the global affiliates consisted of representation from around the world and had never worked face to face prior to this initiative. 

IPM’S SOLUTION

Integrated Project Management Company, Inc. (IPM) developed and implemented a strategy for harmonizing the document management processes of 15 global business units within a six-month period. Key elements of this solution included the following:

  • Promoting a common vision for the new document management system
  • Educating the business units on the process required to perform harmonization
  • Sharing lessons learned and conclusions between each of the global business units
  • Developing a mutual appreciation for the existing processes performed across global sites
  • Facilitating team workshops and group exercises for developing harmonized processes
  • Documenting all of the team’s findings and conclusions
  • Ensuring completion of all preparatory work and follow- up through each business unit


 PROJECT RESULTS

Immediate results recognized by the company included the following:

  • File folder structures and an archiving process were created that facilitated the ease of retrieval and assembly of submission documents. This ultimately reduced the overall submission timeline.
  • Relationships within the individual business units were established and/or strengthened.
  • Common document management processes were developed, improving communications, expectations, and training capabilities within the individual business units. This allowed the company to exploit the full capabilities of the document management system.
  • Project sub-team activities were driven by the Project Plans and Schedules to provide a mutual understanding of what had to happen or to mitigate risks that could have been addressed by others. Individuals and sub-teams knew what actions must come first, what outcomes were required, and the deadlines for completion.
  • Through Project Team Reviews, sub-teams were brought together to collaborate on problems and issues affecting the program and share their Lessons Learned. The sub-teams no longer worked independently of one another. 
  • To provide continuous promotion of teamwork, communication, and focus to project objectives, IPM developed communication processes to provide a mutual understanding of activity within and among the teams. IPM also developed processes and mechanisms to keep upper management informed of the critical issues and progress. This helped to ensure support for the Program at the highest levels of the organization while adding incentive for team members to receive recognition for their actions. 
  • As an adjunct to the harmonization exercises, the individual business units identified incompatible business policies. These policies were broader in scope than the tactical use of the new document management system and affected the effectiveness of the business unit(s). The teams were able to develop and implement recommendations to reduce and/or eliminate these disconnects.