Q&A library
Long-tail life sciences insurance questions, answered in depth.
Detailed answers to the specific questions life-sciences operators ask before signing a sponsor MSA, registering as a 503B, joining a GPO, or onboarding a new sponsor relationship. Each entry is a full-page treatment of one question.
Question
Does a 503B outsourcing facility need dedicated product recall coverage?
Why FDA-recall extensions on standard products liability policies are typically insufficient for 503B outsourcing facilities, and what dedicated recall coverage looks like.
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Question
Which MSA clauses require additional insured status for products and completed operations?
How sponsor MSAs require additional insured for products and completed operations, why blanket AI endorsements often exclude it, and what ISO CG 20 37 looks like in practice.
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Question
Does clinical trial liability insurance cover investigator-sponsors and clinical sites?
How clinical trial liability policies handle investigator-sponsor coverage, what sponsor IND-holder responsibilities look like for insurance, and where CROs sit in the structure.
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Question
How does USP 797 / 800 compliance compare to FDA cGMP for insurance underwriting?
USP 797 and USP 800 vs FDA cGMP — which standard applies to which compounder, how insurance carriers underwrite each, and what compliance documentation matters at renewal.
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Question
What insurance options do GLP-1 compounding pharmacies have right now?
The GLP-1 compounding insurance landscape — carrier exclusions, products liability availability, druggist PL options, and how 503A and 503B compounders are navigating the firestorm.
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Question
What insurance coverage does a medical device manufacturer need to supply a GPO?
Group purchasing organization (GPO) supplier insurance requirements for medical device manufacturers — products liability limits, additional insured, hospital purchase contract pass-through, and credentialing platform enforcement.
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Question
What insurance does PBM credentialing require for a pharmacy?
Pharmacy benefit manager (PBM) credentialing insurance requirements — druggist professional liability, products, cyber, HIPAA, and carrier rating. Why credentialing failure locks the pharmacy out of reimbursement.
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Question
Does a 503A compounding pharmacy actually need products liability insurance?
When 503A compounding pharmacies need products liability coverage, why druggist professional liability alone is insufficient at scale, and how PBM credentialing and accreditation interact with products coverage.
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Question
How much cyber liability does a CRO handling PHI typically carry?
Cyber liability sizing for CROs handling protected health information — limits by subject count, PHI sensitivity, and sponsor-required minimums. HIPAA breach response, regulatory defense, and ransomware coverage.
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Question
How do I evaluate the insurance section of a sponsor MSA before signing?
A practical walkthrough for life-sciences operators reviewing the insurance schedule of a sponsor master services agreement — what to look for, what to push back on, and how to identify hidden compliance traps.
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Question
Does a pre-revenue clinical-stage biotech need D&O insurance?
Why pre-revenue clinical-stage biotechs typically need D&O coverage despite having no commercial product — investor disputes, regulatory investigations, employment claims, and Side A protection.
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Question
Where do CDMOs and CROs have leverage to negotiate sponsor MSA insurance terms?
A practical map of which sponsor MSA insurance terms are negotiable versus universally enforced — limits, AI wording, indemnity, survival, and form requirements.
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Question
How does CDMO claims history affect insurance renewal pricing?
How insurance carriers underwrite CDMO renewals based on prior claims experience, what counts as a "clean" history, and how operators can mitigate the impact of prior claims at renewal.
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Question
How much does life sciences insurance cost by company revenue?
Typical Texas life-sciences insurance premium ranges by company revenue band and sub-vertical — CDMO, CRO, medical device, biotech, compounding pharmacy, 503B outsourcing.
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Question
Can a CDMO share insurance with its sponsor under the MSA?
Whether CDMOs and pharma sponsors can share insurance programs under a master services agreement — the legal and practical limits, OCIP/CCIP structures, and why standalone CDMO programs remain standard.
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