Pharma Pen Testing: GxP, 21 CFR Part 11 & Nation-State Risk

Contributors

Shantanoo Govilkar
Shantanoo Govilkar
SVP Strategic Solutions Risk & Cybersecurity Solutions

Two regulators grade your pen testing program. Only one of them is the FDA.

  • +50% jump in FDA CDER warning letters in FY2025
  • 6 to 18 months of attacker dwell time in documented pharma breaches
  • ~30 multinational pharma, manufacturing and energy firms hit in one APT41 campaign

Inside this ebook: Two ready-to-use frameworks. The GxP-IP Dual Scoping Matrix lets you satisfy the FDA and protect your IP in one engagement. The Pharma Threat Exposure Index gives you a 100-point score that shows your board exactly where you stand.

 

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