NSF Research Reveals Nearly One in Four European Pharma Companies Face Critical Regulatory Risks

Oxford, UK — Nearly one in four European pharmaceutical companies remains vulnerable to regulatory risks due to inadequate quality systems, according to new research from NSF, a leading global public health and safety organization.

The independent study conducted by Opinium surveyed 100 senior regulatory and quality leaders across Europe and the UK. It found that 23% of companies operate with only basic compliance-level quality systems, exposing them to significant regulatory and operational risks as regulatory authority expectations increase.

“European life sciences organizations are facing profound structural changes, from stricter regulatory frameworks, including the EU Clinical Trials Regulation and multiple recently approved and proposed GMP changes, to persistent supply chain challenges and rapid digital transformation,” said Dr. Peter Gough, vice president of pharmaceutical services at NSF. “Our research provides companies a vital benchmark of quality maturity, inspection readiness and data integrity.”

The research identified three main vulnerabilities that threaten industry stability:

• Supply chain risks: 32% of leaders identified raw material sourcing as their most pressing challenge, with ongoing struggles in component authentication and verification critical to regulatory compliance.
• Data integrity challenges: Despite 46% of companies increasing technology investments over the past three years, 58% report difficulties integrating data across multiple systems.
• Quality system maturity: While 53% of companies have implemented advanced risk-based systems, 23% still operate at basic compliance levels.

Sustainability has moved from the margins to the core of quality and compliance frameworks, with 84% of organizations now embedding environmental metrics into their quality management systems. This integration not only helps strengthen inspection readiness but also mitigates operational risks and enhances companies’ social license to operate. The study found that 56% of companies prioritize energy efficiency in GMP operations, 50% target carbon footprint reduction and 48% conduct packaging sustainability initiatives.

Compliance pressure is driving transformation. “The research shows 37% of leaders cite compliance to Annex 1 as their top challenge, and it's driving real change: more training, more cross-functional task forces and redesigned quality systems,” said Dr. Kay Hukin, executive director, Pharma Biotech at NSF. “This is compliance pressure turning into performance advantage, and it’s reshaping how the industry thinks about risk and readiness. Organizations that master integrating technology, culture and capability will define the next era of pharmaceutical excellence. Those that don’t risk being left behind.”

Quality culture is also a critical success factor, with 33% of industry leaders prioritizing cultural transformation over purely technical controls. “Regulatory compliance is no longer the ceiling; it’s now become the starting point,” Hukin added.” Companies that treat regulatory guidelines as a framework for innovation rather than a limitation will succeed. Blending technology, culture and capability to build systems that are not just audit-ready, but future-ready, will define the next era of quality and resilience.”

The study highlights a critical skills gap, emphasizing the need for talent to combine regulatory expertise with data science, risk management and change leadership. The next generation of compliance professionals must be fluent in both regulation and analytics.

Digital transformation barriers remain: 58% of organizations struggle with data integration, even as 46% increased technology investments over the past three years; implementation gaps persist in AI, analytics and IoT adoption.

“The most resilient organizations are those balancing human and digital transformation, building quality culture while strategically deploying technology,” Gough said. “This integrated approach is becoming essential as global regulatory expectations evolve beyond basic compliance toward sustained quality performance.”

NSF’s advisory and training services support organizations implementing the report's strategic recommendations.