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CoverXSpecialty’s Life Sciences Insurance program is designed for agents placing product, professional and general liability for manufacturers, clinical sponsors, contract organizations and other life-science operations. This market focuses on science-driven exposures — pharmaceuticals, biologics, medical devices, contract manufacturers, CROs, clinical trial sponsors, durable medical equipment and dietary supplements — and offers tailored forms, capacity and underwriting for those risks. Overview of the Program As a general agency and carrier program, CoverXSpecialty provides a focused Life Sciences Insurance solution that balances industry knowledge with flexible placement options. The program provides both primary and excess limits (capacity up to $5,000,000) and makes available product/completed operations, professional liability and general liability coverage appropriate to manufacturing, research, clinical and distribution operations. Ideal Accounts and Appetite Target risk size: Accounts up to $1 billion in revenue; start-ups and early commercial companies are acceptable when supported by strong risk management and regulatory controls. Target classes include: Pharmaceuticals (including biologics) Contract manufacturers Generics (prescription and OTC) Clinical trial sponsors and investigators Contract research organizations (CROs) Durable medical equipment suppliers Medical devices (FDA Class I and II) Dietary supplement manufacturers and distributors Typical fits are clients with documented quality systems, clear supply chains, and well-defined clinical or manufacturing protocols. Accounts with complex global distribution, significant recall history, or high-risk Class III devices may require specialized placement and are reviewed on a case-by-case basis. Coverage Highlights and Advantages Capacity: up to $5,000,000 available for primary or excess policy limits. Coverage forms: Products/Completed Operations and Professional and General Liability; products and professional coverage usually written on a claims-made basis while other general liability coverages are provided on an occurrence basis. Defense provisions: Defense within the limit for claims-made coverages; defense in addition to the limit for occurrence coverages. Contractor/vendor features: Automatic Additional Insured status for life science contractors, sites, investigators and vendors where appropriate. Underwriting experience: Underwriters familiar with FDA-regulated products, clinical trial exposures and GMP/GCP risk controls. Underwriting Notes and Minimum Premiums Underwriting focuses on product risk profile, regulatory status, quality systems, distribution channels, clinical trial protocols and loss history. Required submission items often include completed applications, current loss runs, regulatory/clearance documentation (e.g., FDA status), product lists and descriptions of manufacturing controls or trial oversight procedures. Minimum premiums and terms vary by account and carrier — submit for quote to get state-specific pricing and eligibility. Territories and Admitted Status Program availability: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, DC, WV, WI, WY. Admitted status: No States. Coverage is generally placed on a non-admitted/surplus lines basis; confirm state eligibility and filing requirements at submission. Why Place Life Sciences Business with CoverXSpecialty CoverXSpecialty combines specialized underwriting expertise in life sciences with programmatic flexibility for both start-ups and established manufacturers. Agents benefit from access to tailored forms, automatic additional insured language for contractors and targeted capacity up to $5M. Underwriters understand clinical and regulatory exposures, which speeds accurate risk assessment and improves quote quality. Example scenarios you might place here: a mid-sized contract manufacturer seeking primary products liability and professional liability for contract sterile fills; a CRO sponsoring multi-site clinical trials needing limits for investigator and vendor exposures; or a small medical device company with Class II devices requiring product liability and recall-response underwriting. Submission Tips Provide complete applications and recent loss runs (minimum 5 years if available). Include product descriptions, FDA or regulatory status, manufacturing/quality procedures and distribution territories. For clinical trials, include study protocol overview, investigator qualifications and monitoring procedures. Flag any prior recalls, regulatory actions or product liability claims up front to avoid delays. Frequently Asked Questions What types of accounts are a good fit for CoverXSpecialty’s Life Sciences program?Accounts with pharmaceutical, biologic, device, CRO, clinical trial sponsor or contract manufacturing exposures are a good fit, especially when they can demonstrate quality systems, regulatory oversight and clear distribution channels. The program accepts start-ups through larger companies (up to $1B revenue). What limits and coverage forms are available?CoverXSpecialty offers up to $5,000,000 in primary or excess limits. Products and professional liability are typically provided on a claims-made basis; other general liability coverages are provided on an occurrence basis. Defense is within the limit for claims-made and in addition to the limit for occurrence coverages. Is this program admitted in all states?The program’s admitted status is listed as “No States,” so placements are generally non-admitted/surplus lines. Availability is shown for specific states; confirm state eligibility and filing requirements at submission. What information does underwriting need for an efficient quote?Provide completed applications, recent loss runs, product lists, regulatory/FDA status, manufacturing or clinical protocols, quality control processes and details on distribution. Early disclosure of recalls or regulatory actions helps speed the review. How long does a typical quote turnaround take?Turnaround varies by complexity but simple, well-documented submissions often receive an initial response within 7–14 business days. Complex manufacturing or international distribution risks may take longer. Need help placing an account? Connect with a market specialist.

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Overview of the Program From Citadel Insurance Services Citadel Insurance Services’ Life Science Insurance program (BioPAC) is a specialty wholesale product built for companies across the life sciences spectrum — from preclinical startups to large, established manufacturers. The program is designed to be flexible and scalable so you can place accounts with complex product, clinical trial and biomanufacturing exposures that standard markets may decline or limit. Ideal Accounts and Appetite This program targets a broad set of life science risks. Typical accounts that fit well include: Medical device manufacturers and medical device software companies Pharmaceutical and biologic developers (including drug discovery and bio-engineering) Medical foods, cosmetic drug companies and non-medical biotechnology firms Life science product development services and product testing laboratories For-profit and non-profit research institutions Medical product distributors and contract research/contract manufacturing organizations Coverage Highlights and Advantages BioPAC offers a modular set of coverages and endorsements to match specialized exposures common in life sciences: General and product liability tailored for biological agents and medical devices Clinical trials liability and clinical trials medical expense coverage Professional liability options for researchers, labs and developers Data breach expense and data breach economic liability extensions for software and device data Voluntary products recall and designated products coverage Abuse & molestation and punitive damages where allowable by law (subject to underwriting) Flexible extended reporting and circumstance reporting options These coverages make the program practical for accounts that combine product, clinical and cyber exposures or that require broader testing and recall protection. Underwriting Notes and Submission Requirements Citadel underwrites this program through wholesale placement. Underwriters expect clear documentation of product lifecycle, clinical trial protocols (where applicable), quality control procedures, and distribution channels. Provide: Summary of operations and product descriptions Clinical trial protocols, enrollment size and safety monitoring when applicable Regulatory status (e.g., FDA filings, CE marks) and quality management systems Claims history and prior disciplinary or product recall history Minimum premium information varies by risk and market placement — contact Citadel for program-specific minimums and quotation turnaround. Territories and Admitted Status The program is available across a broad set of U.S. jurisdictions, including: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, DC, WV, WI and WY. Note: This program is placed on a non-admitted/surplus lines basis (no admitted filings). Confirm surplus lines requirements and tax/filing procedures for the insured’s domiciliary state before submission. Why Work With Citadel Insurance Services on Life Science Business As a specialty wholesale broker, Citadel offers tailored placement expertise for complex life science exposures and access to markets that understand product, clinical and cyber overlaps. Underwriters are experienced with research institutions, contract labs and product manufacturers, enabling pragmatic solutions where standard markets may restrict coverage or capacity. Example Account Scenarios You have a start-up developing a novel implantable medical device with upcoming first-in-human trials. BioPAC can combine clinical trials coverage with product liability and cyber extensions for device software. You represent a contract testing laboratory that handles biologic samples and provides analytical services to multiple sponsors. The program can provide laboratory liability, biological agents liability and professional liability in a single placement. Frequently Asked Questions What types of life science accounts are the best fit for this program?The program fits medical device and device software firms, drug and biologic developers, product testing labs, research institutions and service organizations that need combined product, clinical and cyber coverages. Is this an admitted program and in which states is it available?BioPAC is placed on a non-admitted/surplus lines basis. It is available in the listed states (AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, DC, WV, WI, WY). Confirm surplus lines requirements for the insured’s domicile before submission. What documentation does Citadel require for submission?Provide a clear operations summary, product descriptions, clinical trial protocols (if applicable), regulatory and quality control documentation, and recent loss history. More detailed checklists are available from Citadel upon indication of interest. Need help placing an account? Connect with a market specialist.

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Target Classes: Pharmaceuticals & Biotech Products Medical Devices / Products Biologics (Animal & Human) Nutraceuticals Human Clinical Trials Overview of the Life Sciences Program from BSR Insurance BSR Insurance provides a focused Life Sciences Insurance program for agents placing product, professional and clinical-trial exposures for companies operating in the pharmaceutical, biotech, medical device and nutraceutical sectors. As an Excess & Surplus (E&S) lines broker, BSR leverages relationships with multiple non-admitted carriers to structure flexible terms for hard-to-place, highly regulated and emerging risks. Ideal Accounts and Appetite This program fits a broad range of life sciences businesses, including early-stage R&D firms through mid-sized manufacturers and distributors. Typical eligible accounts include: Pharmaceutical and biotech R&D and manufacturing Medical device development, manufacturing and distribution Human and animal biologics Nutraceutical manufacturers and distributors Human clinical trials based in the U.S. (domestic only) Restricted or ineligible risks include products containing Ephedra and any foreign clinical trial activity. If you have a client launching a novel medical device or preparing for first-in-human studies, BSR can help place those higher-exposure accounts through creative E&S solutions. Coverage Highlights and Advantages Products Liability, General Liability and Professional Liability (typically Claims-Made) Occurrence-form coverage available for limited classes Limits up to $5 million (available on a primary or excess basis) Flexible deductible and Self-Insured Retention (SIR) structures Unsupported excess capacity available Vendor’s coverage can be included Prior Acts (retroactive) coverage offered where appropriate These features help protect insureds against third-party claims arising from product defects, design or manufacturing errors, and professional errors during clinical development. Underwriting Notes and Minimum Premiums Underwriting focuses on product risk profile, clinical trial phase and controls, manufacturing practices, and distribution channels. Minimum premium for placements typically starts at $4,500, with many accounts averaging near $20,000 depending on exposures, limits and attachment points. Common deductible levels are $2,500–$5,000, while minimum SIRs generally start at $25,000. Territories and Availability BSR writes this Life Sciences program on a non-admitted basis across most U.S. states, including: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, DC, WV, WI, and WY. Why Work With BSR Insurance? BSR combines life sciences industry knowledge with broad access to E&S markets, making it a practical partner for agents placing complex or non-standard accounts. Their underwriting team is experienced in evaluating emerging technologies and tailoring terms—whether a client needs primary limits, excess capacity, prior acts protection, or customized SIR structures. Example scenarios that fit well: You represent a biotech start-up advancing to Phase I human trials that needs professional liability and product liability with prior acts coverage for prior research. You have a mid-market medical device manufacturer seeking primary limits and an unsupported excess layer to cover new distribution channels. Frequently Asked Questions What types of accounts are a good fit for this program?Ideal accounts include pharmaceutical and biotech companies, medical device manufacturers, nutraceutical firms, and organizations conducting U.S.-based human clinical trials. Is coverage available for foreign clinical trials?No. This program excludes foreign clinical trials; only clinical trial exposures within the United States are eligible. What liability limits are available?Limits up to $5 million are available on a primary or excess basis. Unsupported excess options may also be offered depending on the placement. What are common deductible and SIR options?Deductibles commonly range from $2,500 to $5,000. Minimum SIRs typically start at $25,000, subject to risk characteristics. Is this program admitted or non-admitted?This program is placed on a non-admitted basis through various E&S carriers across most U.S. states. Need help placing an account? Connect with a market specialist.

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