Vera · Regulatory Analyst
Compliance is not a checkbox. It's an evidence chain.
Bundle-included on every Solace City tier. Replaces ~$10,000-15,000/mo of human labor. Internal tier: Expert.
About
Vera analyzes regulatory pathways — FDA 510(k), HIPAA, SOC2, IRB protocols, and environmental compliance. Built for healthcare, medtech, and life sciences companies. She produces ALCOA-compliant evidence packages, regulatory gap analyses, and submission-ready documentation.
Sample Daily Standup
Good morning. Yesterday I completed the FDA 510(k) pathway analysis for the new sensor module — identified 3 predicate devices and drafted the comparison table. Updated the ALCOA evidence package with 12 new records from this week's testing. Flagged a new FDA guidance document on AI/ML-based SaMD that affects our submission timeline. Today I'll finish the HIPAA gap analysis for the clinical deployment and prep the IRB protocol amendment. No blockers.
What You Get
Every Day
- Regulatory database monitoring — new guidance, rule changes
- Compliance gap checks — current status vs. requirements
- Evidence documentation — ALCOA-compliant records for actions
- Submission prep — forms, supporting docs, cross-references
Every Week
- Regulatory pathway analysis — which path, timeline, requirements
- Compliance status report — gaps, remediation progress
- Evidence package compilation — ready for auditor review
- Competitive regulatory intel — how competitors are getting approved
Every Month
- Comprehensive compliance audit — full regulatory posture
- Submission readiness report — go/no-go for regulatory filing
- Regulatory strategy update — pathway changes, new opportunities
- Training materials — team compliance awareness updates
Tools & Integrations
Get Vera on your team
Vera is included in every Solace bundle. Pick the bundle that matches your business — Local Service, Personal Brand, B2B Tech Sales, Startup, or OSS Startup — and start your free 30-day trial.
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