M&A Regulatory Support

Challenge

An EU-based large pharmaceutical company was facing a large regulatory burden due to M&A activities after acquiring a diverse portfolio of established products and needed global / local affiliate support for the transfer of licenses. Proclinical Consulting was requested to manage the transition between existing staff and new staff, ensuring that all maintenance activities and regulatory strategy were completed.

Consulting Services

Solution


Proclinical Consulting identified a staff augmentation model to provide sponsors with the ability to address these needs while maintaining flexibility and reducing fixed costs. To rapidly attract and recruit qualified employees for this turn key situation Proclinical Consulting leveraged on-demand access to top regulatory talent. The Proclinical team completed variations and renewals for registered products in assigned countries. Proclinical performed the majority of work remotely but did have staff working onsite at the start of the project to support the reorganization and ensure business continuity. Limited client interactions were required to prepare submissions. 

Proclinical was issued client laptops to easily access data and client systems. This allowed Proclinical to be seen as a true extension to the client’s regulatory team. On-site presence of Proclinical staff allowed access to paper filing systems for older products which were in the process of being uploaded to a document management system. This in combination with the local language skills of Proclinical experts enabled Proclinical staff to better understand history of the legacy products.

Outcome


  • On-boarded 30 people, for a large portfolio of products.
  • A smooth transition which resulted in no impact to the ongoing maintenance and renewal work
  • Helped identify processes that can be improved and facilitate submission work
  • Transferred all work back to the client in an up-to-date state
  • Client continues to utilize Proclinical Consulting services
  • Program governance structure with clear responsibilities and common decision board

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