Challenge
A top 40 biophara company was seeking a regulatory outsourcing partner with expertise and global reach to manage and perform regulatory affairs and operations activities in support of legacy marketed products – 700+ active licenses, 20+ countries. Goals included cost efficiency, continuous process improvements, operational excellence, high quality, timely delivery, flexible resourcing and business continuity. ̽»¨ºÏ¼¯ Consulting was requested to manage all the LCM activities related to maintenance activities.
Consulting Services
Solution
̽»¨ºÏ¼¯ Consulting assumed a Global Regulatory Affairs (GRA) role for three defined product portfolios. We adopted a model with defined project phases to establish clear roles, responsibilities, processes and project plans addressing communication, risk mitigation, governance, and training. We tracked, reviewed and assessed Key Performance Indicators (KPIs), and integrated fully with client systems.
Outcome
- Internal staff refocused on development projects, reduced number of contractors and reduced administrative burden on GRA and stakeholders
- Ensured a smooth transition which had no impact to the on-going lifecycle maintenance
- ̽»¨ºÏ¼¯ Consulting is considered a key part of the Regulatory team by GRA and all other key stakeholders
- Identified areas of process improvement and has made this a continuous effort for maximum efficiency
- Ensured on-time delivery of high quality and complex regulatory submissions