This blog talks about building a regulatory intelligence function in life sciences industries with strategies for FDA/EMA compliance and clinical trials.
For years, the life sciences industry has been reactive to changing regulations—whether from the FDA, EMA, or emerging markets. This reactive model is costly and unsustainable.
In today’s fast-moving, complex global environment, Regulatory Intelligence is a strategic necessity. It enables organizations to anticipate, analyze, and act on regulatory changes, transforming compliance into a competitive advantage.
Why Proactive Regulatory Intelligence Matters
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Since 2000, pharma companies have paid over $50 billion in noncompliance fines.
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Developing a drug takes 10–15 years and $2 billion, yet 90% of candidates fail, often due to misaligned or delayed submissions.
A proactive regulatory intelligence function reduces these risks by preparing teams before issues arise.
https://www.freyrregintel.com/how-to-set-up-a-regulatory-intelligence-function-in-your-organization/
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