Pharmaceutical manufacturers, distributors, and research organizations face a dual security mandate: strict federal regulatory compliance for controlled substances, and protection of intellectual property that may represent billions of dollars in research investment. Protective Resources helps pharmaceutical clients meet both obligations with independent, defensible security programs.
DEA Physical Security Compliance
DEA registrants must provide effective physical security controls for controlled substances under 21 CFR §§ 1301.71–1301.76. The requirements are specific — and DEA evaluates them during registration and inspection. We assist with:
- Cage, vault, and safe specifications for Schedule I–V storage meeting DEA construction requirements
- Alarm system design and monitoring arrangements satisfying DEA expectations for controlled substance areas
- Access control and accountability procedures for manufacturing, distribution, and research registrants
- Pre-registration security readiness reviews and support responding to DEA inspection findings
- Diversion risk assessments covering both external threats and employee diversion
FDA and Supply Chain Security
Beyond DEA requirements, FDA-regulated operations carry their own physical security implications — protecting product integrity under cGMP, securing warehousing and distribution against theft and tampering, and supporting Drug Supply Chain Security Act (DSCSA) obligations. Our assessments address facility security as a component of product integrity and regulatory readiness.
Intellectual Property Protection
A pharmaceutical company’s most valuable assets are often invisible: compounds in development, clinical trial data, manufacturing processes, and trade secrets. Physical security is a critical layer of IP protection:
- Laboratory and R&D facility access control zoning, with audit trails for sensitive areas
- Visitor, vendor, and contractor screening and escort procedures
- Protection of pilot plants and scale-up facilities where processes are exposed
- Security standards for third-party and contract manufacturing (CDMO) site evaluations
Independent Assessments That Withstand Scrutiny
Whether the reviewer is a DEA diversion investigator, an FDA inspector, or opposing counsel, our vulnerability assessments and basis of design documents are independent, vendor-neutral work products. We also provide expert witness support in matters involving pharmaceutical facility security.