Planning and Management of Global Post-Approval Regulatory Activity in Pharma:
Intense global competition is driving planning organizations to shift focus from managing regulatory activities for products in development. Instead, focus is redirected to planning the activities in support of mature product portfolios.
The Regulatory Affairs (RA) group at the headquarters of a major Global Pharma company was plagued by a lack of planning (especially with respect to resources), ambiguous and conflicting organizational priorities, and complex and changing regulatory requirements. A key factor was the high-level of collaboration required of disparate internal groups for post-approval regulatory approval to occur. The framework UMT introduced helped increase revenue by almost 400% over 3 years and significantly increased targeted 5th year sales for mature product portfolios launched in new markets.