Overview

A large global pharmaceutical company approached G&L Healthcare Advisors to conduct an in-depth assessment of its Chemistry, Manufacturing, and Controls (CMC) function.

The goal was to strategically align resources with corporate objectives while efficiently managing lifecycle activities.

This engagement aimed to develop a three-year transformation roadmap to optimize global operations, resource allocation, and process efficiency.

Challenges

The company encountered multiple challenges in its CMC function that required strategic focus and alignment:
Global resource deployment: Balancing in-house teams with outsourced partners presented logistical and operational challenges.
Managing complex stakeholder relationships: The CMC function required careful coordination across diverse internal and external stakeholders.
Enhancing process excellence: The need to meet both regulatory and corporate objectives demanded improvements in process efficiency and standardization.
Planning transformation: A strategic transformation plan was necessary to streamline the global CMC function, ensuring scalability and regulatory compliance.

G&L’s Approach and Solution

G&L deployed a senior management consultant with expertise in Regulatory Affairs and CMC to lead the project, addressing each challenge with targeted solutions:
Data room creation: G&L’s project manager compiled essential documents, including strategic objectives aligned with regulatory targets, transcripts from stakeholder interviews, detailed resource analysis of CMC activities, and aglobal footprint review of partners and suppliers.
Process mapping and analysis: Using the SIPOC (Suppliers, Inputs, Processes, Outputs, Customers) methodology, G&L mapped the CMC function. This comprehensive review of Standard Operating Procedures (SOPs), work instructions, and quality documents highlighted areas for improvement.
Technology stack evaluation: The existing technology stack was assessed for future scalability and integration potential, ensuring that systems could support the planned transformation.
Interim assessment report: An interim report with recommendations was delivered to global CMC leadership, providing key insights into resource optimization and process enhancements.
Transformation roadmap: G&L created a detailed three-year implementation plan, equipping the company with a clear, actionable roadmap for making critical investment decisions and achieving transformation goals.

Impacts and Outcomes

The project was delivered on time and implementation is currently underway, overseen by G&L’s delivery team. The following outcomes are expected:
Efficiency gains: The transformation is projected to save the company several million dollars over the next three years.
Optimized resources: Improved alignment of global resources with corporate and regulatory objectives.
Scalability: Enhanced scalability and readiness for future challenges, backed by a refined technology infrastructure and streamlined processes.