TITLE
CASE STUDY -
Managing corporate separation and meeting regulatory requirements
Corporate Separation
CLIENT
Fortune 100 diversified medical products and pharmaceuticals organization
STRATEGY
As part of a corporate separation, a Fortune 100 diversified medical products and research-based pharmaceuticals organization needed to separate its PharmacoVigilance (PV) processes and systems between the two new corporate entities.
TRANSFORMATION
Peritius was engaged to manage the separation of the firm’s PV medical functions, PV systems support function, and PV and medical communications systems and data. To support this effort, Peritius:
- Led and facilitated the decisions regarding which entity would own which system
- Created a knowledge transfer plan for the PV systems support organization that could be duplicated for any entity that lacked that function
The client required that on Day 1 both corporate entities meet regulatory reporting commitments for drug safety and that transitional service agreements (TSA) were established to provide ongoing operations support through the separation.
RESULT
Both PV organizations were provisioned for short- and long-term success. On Day 1 both corporate entities met regulatory reporting commitments for drug safety. The client’s plan for TSA termination by 24 months after Day 1 was on schedule. All expected benefits were met and the transition office requirements were satisfied.
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CERTIFIED BY:
EDWOSB (Women-Owned Small Business) Federal Designation
Women’s Business Enterprise (WBE) City of Chicago and State of Illinois