Insurance for Life Sciences Companies

Corrective and Preventive Actions (CAPA), enforced by the FDA, are critical for ensuring product quality and regulatory compliance in the life sciences industry. CAPA is a two-step process: 1) addressing immediate issues (corrective actions) and 2) preventing their recurrence (preventive actions). Corrective actions are reactive, while preventive actions are proactive, focusing on eliminating potential nonconformities. CAPA programs are rigorously evaluated during FDA inspections and ISO audits, with common triggers including non-conformities, customer complaints, and audit findings. Effective CAPA implementation involves early adoption, centralized data management, risk management integration, and root cause analysis. A robust CAPA system not only ensures compliance but also mitigates liability risks, enhances product quality, and prevents minor issues from escalating into significant problems.

Vivaria are specialized facilities designed to accommodate controlled environments for animal research, requiring meticulous planning, robust infrastructure, and stringent operational protocols. Key considerations include pre-planning for activities, species, and potential expansions; ensuring animal welfare through proper housing, environmental controls, and waste management; and mitigating risks such as flooding, fire, and cross-contamination. Facilities should be constructed with fire-resistant materials, incorporate redundancy in critical systems, and maintain emergency power and ventilation. Fire protection measures, including sprinkler systems and fire detection, are vital, alongside security features like perimeter fencing, camera surveillance and access control. Effective risk management involves contingency planning, accurate valuation of animals and research investments, and collaboration with local fire departments. Compliance with regulatory frameworks, such as the Animal Welfare Act and NFPA 150, is critical to conserving safety and operational integrity.

Once a product hits the market, it is essential to establish, implement, and regularly update a robust safety monitoring program to ensure ongoing patient safety. The program enables a dedicated team of professionals from various departments to quickly address unexpected issues, review complaints, malfunctions, and injuries, and identify trends. This provides senior management with the insights needed to make informed decisions and reduce the risk of future harm. 

Disasters—from natural events to supply chain disruptions—can threaten your life sciences organization. A strong Business Continuity Plan (BCP) is essential to protect research, assets, and operations. A BCP minimizes downtime, safeguards key assets, and ensures rapid recovery after a crisis. It helps you prepare for risks, respond quickly to emergencies, and restore operations efficiently. A proactive Business Continuity Plan can help to protect your business, minimize risks, and stay prepared for any challenge may arise.