Overview 

G&L Healthcare Advisors was engaged by a client following a successful corporate merger that revealed significant opportunities for manufacturing site rationalization across the global supply chain. 

The client faced challenges in balancing the rationalization initiative with ongoing revenue-generating activities and required an outsourcing partner to manage this transition effectively.

Challenges

The client encountered several key challenges during the global supply chain rationalization initiative:
Resource burden: The rationalization process imposed a significant resource burden on internal teams, threatening the continuity of “business-as-usual” activities.
Compliance with regulatory requirements: The client needed to ensure that all manufacturing documentation met Chemistry, Manufacturing, and Controls (CMC) regulatory standards and current requirements.
Global coordination: Effective collaboration across multiple manufacturing sites was essential to streamline operations and enhance efficiency.

G&L’s Approach and Solution

G&L employed a targeted approach to facilitate the client’s manufacturing site rationalization. Key activities included:
Centralized project team: G&L assembled a centralized project team in a near-shore location to support the client post-merger, ensuring efficient communication and collaboration.
Global site documentation review: A thorough review of global site documentation was conducted to identify areas for improvement and standardization.
Gap analysis: G&L performed a comprehensive gap analysis of manufacturing documentation against CMC regulatory documentation and current regulatory requirements, ensuring compliance.
Regulatory documentation support: G&L assisted in the authoring and submission of all regulatory documentation on a global basis, streamlining the process for the client.

Impact and Outcomes

As a result of G&L’s support, the following was achieved: 
Successful rationalization: The global supply chain was successfully rationalized, leading to significant cost savings for the client.
Minimized disruption: The impact on revenue-generating “business-as-usual” activities was minimized, ensuring continuity of operations.
Flexible and scalable resources: The entire rationalization initiative was resourced in a flexible and scalable manner, allowing for adjustments as needed throughout the process.