SixLog Pharma helps sterile compounding operations see their full risk picture: how the operation runs, where it is exposed, and whether the coverage behind it would respond when something slips through. Led by a former 503B owner-operator, we read the operation and the policy from the inside.
The quality system, environmental monitoring, aseptic technique, CAPA discipline. The work that stops the excursion, the failed media fill, the contamination event. Most good operators have built this half with real rigor.
A recall, a regulatory hold, an officer named personally. Whether the coverage behind the business actually responds, or was quietly written for a smaller, simpler version of the company. This is the half almost no one checks.
Most advisors see one half. A quality consultant reads the operation. A broker reads the policy. We read both, because they are the same risk, and we read them the way someone does who has run the facility and made the call.
An operator's read of the facility, quality systems, and practices. Where the operation is vulnerable, what an inspection would surface, and what it means for the business, not just the quality file.
A line-by-line read of the insurance program against what the operation actually does: recall trigger, business interruption from a shutdown, D&O exposure, limits sized to current volume, and the exclusions buried in the endorsements.
Support through 483 responses, warning letters, and remediation. Building a response that addresses the system, not just the observations, from someone who has been on the receiving end of an inspection.
For buyers, investors, and operators in a deal: an independent read on where a target's operation, compliance, and coverage actually stand, before the exposure becomes yours.
We built, ran, and sold a nationally recognized sterile compounding pharmacy and FDA-registered 503B outsourcing facility. We have lived the environmental excursion, the recall decision, the inspection, the choice between stopping a line and pushing through. We know what these operations are exposed to, because we ran one.
After building and selling in this industry, we turned to the risks operators live with but rarely have time to step back and see whole: the operational exposures, the regulatory ones, and the coverage that is supposed to catch what gets through. Seeing that full picture is the work now.
We read coverage the way an operator reads a facility: against what the business actually does, looking for what others miss. When placement is needed, we work with a specialty life science insurance brokerage with real depth in reviewing and structuring policies for high-hazard risk.
This is not theory from the sidelines. We are actively engaged today, advising sterile compounding operators, supporting regulatory remediation, and conducting operational and coverage due diligence on live transactions. We do this work now, in the field, not from a past life.
When coverage needs to be placed or restructured, we work alongside a specialty life science insurance brokerage with real expertise in reviewing and structuring policies for high-hazard, highly regulated operations.
Most operators have never checked. A short conversation is usually enough to know whether it is worth a closer look. No pitch, no obligation.
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