Regulatory
What you should know
Some industries face rules others don’t. Pharma, banking, food, and insurance operate under sector-specific laws. These include strict approval processes (e.g. FDA/EMA for medicines, MiFID II for financial products). Unlike general compliance, these obligations define your right to enter or stay in the market.
Why It Matters
The main risk is losing your license — not just being fined. In banking or pharma, loss of authorization = no business.
Fines may apply too: up to10% of global turnover (GT) under Digital Operational Resilience Act (DORA), 6%under the Digital Service Act (DSA), and up to 10% under the DMA (Digital market act).
But exclusion is the ultimate penalty
Non-compliance costs 3–5% of revenue. It delays M&A, erodes trust, and invites scrutiny.
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Core Requirements
Across jurisdictions, regulatory compliance regulations converge around three pillars:
secure license to do business
design compliance into your products and or services. For example: food packaging must meet content/space limits; platforms must offer “notice & action” tools under the DSA.
anticipate and influence changes
Strategic Implications
You may need to build your business model around regulation. Approval or implementation can take years. Waiting until rules are finalized is often too late. Early alignment avoids rework, delays, or outright bans.
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Your Leadership Checklist
Map license and approval pathways per market
Track upcoming sector-specific rules (EU/US/Asia)
Build compliance into product design
Embed regulatory experts in product/market strategy
Use scenario planning to test your resiliance
Want the full picture?
Download our executive guide to global compliance expectations and future-proof governance.
