A global pharmaceutical manufacturer partnered with us to enhance compliance oversight and streamline quality assurance processes across its regional operations. By transitioning critical compliance and testing functions offshore, the organisation improved audit readiness, reduced operational errors, and generated significant cost efficiencies. Today, more than 15,000 quality assurance files are audited annually, with a 120% improvement in audit coverage, and millions saved through smarter resourcing and process efficiency.
About the customer
The client is a multinational pharmaceutical company operating across Asia-Pacific, Europe, and North America. With stringent regulatory requirements and an expanding product portfolio, the organisation needed to strengthen its compliance posture and improve operational consistency while managing rising costs.
Challenge
The company faced several pressing issues within its compliance and quality functions:
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Limited visibility and control across multiple regional compliance teams.
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High staff turnover and fragmented processes, creating inconsistency in audit preparation.
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Escalating costs of maintaining in-house testing and compliance operations.
These challenges created risk exposure in a heavily regulated industry and threatened the company’s ability to scale efficiently.
Solution
In 2020, the client established a dedicated offshore compliance and quality hub with our support, beginning with a 10-member compliance audit team.
To ensure seamless integration, the client’s Global Head of Compliance spent four weeks on-site to oversee training, align protocols, and embed consistent operating standards. Key elements of the solution included:
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Structured process frameworks with defined guidelines and audit protocols.
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Regular governance reviews with client sponsors to ensure alignment and transparency.
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Expansion of capability beyond compliance into digital testing and validation functions.
Over time, confidence in the offshore hub grew, leading to steady expansion to 50+ full-time employees, covering compliance audits, regulatory reporting, and software validation.
Outcome
The engagement delivered transformative business outcomes:
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120% increase in audit coverage, strengthening compliance assurance and reducing regulatory risk.
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Significant reduction in error rates, enhancing quality and operational confidence.
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15,000+ quality assurance files reviewed annually, ensuring consistency across regions.
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Cost efficiencies realised through the establishment of an offshore testing and validation team, reducing time and resources needed for in-market software and compliance testing.
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Stronger resilience and scalability, enabling the client to manage growth and new product launches without proportionally increasing overhead.
This partnership transformed the client’s compliance and quality functions from fragmented, high-cost operations into a strategic enabler of regulatory confidence and growth. By embedding consistent processes, offshore scalability, and cost efficiency, the pharmaceutical company strengthened its reputation with regulators, safeguarded market access, and established a foundation for long-term operational excellence.
