The 2025 State of Regulatory Affairs and Compliance Report

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2025 Survey Report Cover

Is your organization prepared for 2025’s regulatory complexities?

The regulatory landscape in 2025 is more complex than ever, with new advancements in AI, gene therapy, and growing concerns about data privacy and sustainability.

The 2025 State of Regulatory Affairs & Compliance Report from RegASK explores how businesses in sectors like life sciences and consumer products can stay ahead of these changes. Drawing on insights from 145+ industry experts, the report outlines key regulatory challenges, the role of AI in compliance, and the risks of falling behind.

Key insights you’ll discover :

  • The impact of escalating regulatory requirements on business growth, innovation, and operational efficiency.
  • How AI is revolutionizing regulatory compliance workflows and alleviating resource strain.
  • The most pressing compliance challenges for 2025, from managing real-world data to addressing AI-related risks.
  • Practical examples of AI-driven solutions helping businesses achieve compliance and avoid costly pitfalls.

Stay Ahead of Regulatory Complexities!

Download the 2025 State of Regulatory Affairs & Compliance Report now to empower your organization with the latest insights into navigating regulatory demands.

Equip your team with the tools to meet evolving compliance standards, protect business priorities, and leverage AI for a strategic advantage.


Resources

EUDAMED Goes Mandatory: Medical Device Compliance Tight…
Medical device compliance tightened across three of the world’s largest markets at once in mid-2026, making devices and IVDs the busie…
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Drug Pricing & Market Access in 2026: Medicare Neg…
Drug pricing and market access moved to the centre of pharma regulation in mid-2026, as the focus shifted from registration to money, pri…
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GMP Enforcement Escalates: FDA Warning Letters, Import …
GMP enforcement escalated noticeably in mid-2026, and manufacturing inspections carried the highest share of risky regulatory alerts among o…
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APAC Import Controls Tighten: Australia Fees, Singapore…
APAC import controls tightened on several fronts in June 2026, with Australia, Singapore, and the Philippines each raising the cost or compl…
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Pesticide & Residue Standards Under Review: Japan …
Pesticide and residue standards faced renewed scrutiny in June 2026, with Japan and Thailand opening consultations on residue limits and Ger…
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Marketing Claims Under Scrutiny: EU Energy Labels, Kore…
Marketing claims came under renewed scrutiny in June 2026, with the EU, South Korea, and Italy each acting on how products are labelled and …
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