Your Challenges
Pharma and biotech companies face threats targeting their most valuable assets:
- Clinical trial data integrity must be protected against tampering that could invalidate study results
- Drug formulations and manufacturing processes are prime targets for industrial espionage
- FDA 21 CFR Part 11 and GxP requirements mandate validated systems with audit trails and access controls
- Research collaboration with universities, CROs, and partners requires data sharing without compromising security
- Manufacturing systems (MES, LIMS, process control) are increasingly connected and vulnerable
- Nation-state actors target pharmaceutical IP, especially during public health emergencies
How We Help
Research Environment Security
We assess and harden the systems that store and process your most valuable data: research databases, electronic lab notebooks, genomics platforms, and clinical trial management systems.
GxP and FDA Compliance Support
We help you implement security controls that satisfy FDA 21 CFR Part 11, EU Annex 11, and GxP requirements. Validated systems, audit trails, electronic signatures, and access controls are all covered.
Manufacturing System Security
We evaluate your manufacturing execution systems, laboratory information management systems, and process control networks for vulnerabilities. Security is implemented without disrupting validated production processes.
On-Premise AI Security
For environments handling proprietary formulations and clinical data, we deploy AI security agents on hardware within your facility. Sensitive research data never leaves your network.
Why Pharma Companies Choose Us
- We understand that validated systems cannot be patched on the same schedule as regular IT. Our security approach works within GxP constraints.
- On-premise AI deployment keeps proprietary research data within your control.
- We have experience with the intersection of IT security, OT security, and regulatory compliance unique to pharma.
- Our continuous testing identifies vulnerabilities in research and manufacturing systems before attackers do.
Get Started
We begin with a scoping session to understand your research environment, manufacturing operations, and regulatory requirements. From there, we design a security program that protects your IP and keeps you compliant.
