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Insurance Buying Guide for Therapeutics Businesses
Which Insurance Should You Consider?
Consider product liability, professional errors and omissions (E&O), cyber liability, commercial property, and cargo and transit. Start with the coverages tied to your day-to-day operations, then use the situations and buying questions below to compare your options.
Product liability
You move a drug or biologic from development into an FDA-regulated clinical investigation under an IND, manufacturing, treatment access, or commercial sale.
Ask a specialist how the proposed product-liability wording treats the specific product, stage, indication, territories, and allegations. FDA’s IND guidance describes study roles and product stage, not insurance response.[1]
Ask Before Buying
Which candidates, study or sale stages, territories, and product-related allegations are addressed, and what exclusions or sublimits apply?
Professional errors and omissions (E&O)
For an FDA-regulated clinical investigation under an IND, your company sponsors the study, manages operations, analyzes study data, or performs services for another sponsor.
Ask how the proposed terms treat your actual study services and contract duties. Do not assume the line name covers participant injury, sponsor liability, or obligations you accepted in a trial agreement.[1][2]
Ask Before Buying
Which study activities and entities are included, and what forms address participant events, data work, and assumed contract liabilities?
Cyber liability
You receive records or patient information for an IND-regulated clinical investigation, or other study data from sites, investigators, or vendors.
NAIC distinguishes first-party incident costs from third-party claims and says cyber policies are customized. Map study data and vendors before comparing policy wording.[3][4][5]
Ask Before Buying
How do the proposed terms address study data, vendor-held information, response costs, customer claims, and incident notice duties?
Commercial property
You lease a lab or production site, acquire manufacturing equipment, or store product and work in progress.
California’s commercial guide describes property at a location and notes the role of values, covered causes, and deductibles. Schedule each site, machine, inventory, and property owner for the quote.[6]
Ask Before Buying
Which locations, equipment, product, and customer-owned materials are listed, and what valuations, causes of loss, and deductibles apply?
Cargo and transit
For an IND-regulated clinical investigation, you arrange movement of clinical supply or study materials between manufacturers, depots, sites, and couriers.
Ask a specialist which transit wording, if any, fits the actual materials and route, including any temperature, delay, or interruption terms.[6][2]
Ask Before Buying
Which shipments, values, carriers, routes, handling conditions, and transfer points are included, and what temperature, delay, or contamination exclusions apply?
Before an IND-Regulated Investigation
If you plan an IND-regulated clinical investigation, list the sponsor, study sites, investigators, product, and services your company performs. FDA defines the sponsor by who submits the IND in the circumstances it describes; its protocol guidance identifies study design, participants, procedures, tests, and monitoring as details to describe.[1][2]
For an IND-regulated investigation, use those roles in the insurance application and customer contracts. Ask a specialist to identify the forms and exclusions for study operations, participant events, and product allegations.[1][2]
Before Manufacturing or First Sale
List who makes, tests, labels, stores, and distributes each product lot. Include contract manufacturers, storage sites, study destinations, and couriers so the broker can compare the complete operation with proposed property and transit terms.[6][1]
If you plan to withdraw or replace product, ask a specialist whether any separate form is available and what events and expenses it addresses. Do not assume a product-liability label includes recall, participant-injury, or supply-interruption costs.[1]
Providers to Compare by Coverage
Product liability
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10
Professional errors and omissions (E&O)
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10
Cyber liability
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10Commercial property
Alliance Risk
Spot Score
Review Score
Not enough ratings
CFC
Spot Score
Review Score
Not enough ratings
Cargo and transit
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10
Common Questions
Is product liability the same as insurance for an FDA-regulated clinical investigation?
Do not assume so. For an FDA-regulated investigation under an IND, identify the sponsor and your company’s role, then ask a specialist to compare study duties, participant events, and product allegations with the proposed forms.[1]
Read the Full AnswerWhat should I tell the broker before contract manufacturing begins?
For contract manufacturing, list each product and lot, manufacturer, storage site, testing role, shipment route, and whether the destination is an IND-regulated study or commercial sale. Ask how those activities appear in the proposed application and forms.[6][1]
Read the Full AnswerSources and Further Reading
- IND Applications for Clinical Investigations: Overview — U.S. Food and Drug Administration. Opening bullets defining IND use, clinical investigation, and sponsor
Identify the study sponsor and product stage before describing the operation to a broker.
- IND Applications for Clinical Investigations: Clinical Protocols — U.S. Food and Drug Administration. Clinical protocol content on study design, patient selection, procedures, tests, and monitoring
List the study activities, participants, procedures, and monitoring connected to your company’s role.
- Cybersecurity — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber loss categories and customized-policy qualification
- Cyber Insurance: Cybersecurity for Small Business — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts
Compare first-party and third-party examples as prompts for your actual cyber wording.
- Guidance on HIPAA & Cloud Computing — U.S. Department of Health and Human Services, Office for Civil Rights. Questions 1–3 on covered entities, business associates, and cloud services
- Commercial Insurance Guide — California Department of Insurance. Commercial property; inland marine; commercial general liability
Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.
Updated 2026-09-28. Editorial Policy
Get Help With Insurance Buying and Renewals.
Get help buying coverage and managing renewals, with less paperwork for your team. Start with a free consultation.