The Cost of Being Caught Off-Guard is Far Higher
Choose the level of intelligence that fits your risk exposure.
Simple pricing. No contracts. Cancel anytime.
$4.2M+
Average consent decree cost
FDA enforcement actions can cost organizations millions in remediation
18+ months
Typical remediation timeline
Warning letter responses often require 12-24 months of corrective action
3-6 weeks
Lead time advantage
Early signal detection gives teams weeks to prepare vs. react
Starter
For individual professionals staying ahead of FDA shifts
What You'll Achieve:
- Catch regulatory shifts before they become fire drills
- Brief your leadership with confidence
- Reduce time spent monitoring FDA sources
Includes:
- Access to FDA Intelligence briefs (last 30 days)
- Executive summaries + impact analysis
- Email alerts for major developments
- —No archive access
- —No custom briefing requests
Best for: Individual RA/QA professionals who need to stay informed
Professional
For teams making compliance, legal, and operational decisions
What You'll Achieve:
- Align executives before enforcement—not after
- Reduce compliance surprises by 80%+
- Cut senior staff research time by 10+ hours/week
- Get custom intelligence on emerging issues
Includes:
- Everything in Starter, plus:
- Full searchable archive of FDA Intelligence briefs
- Custom briefing requests (3-5 business day turnaround)
- Priority alerts for high-impact FDA actions
- Executive-ready framing for leadership discussions
The ROI Case:
At $497/month, if Nysom helps you avoid one missed regulatory signal per year, you've likely saved 10-100x your subscription in avoided remediation, inspection findings, or competitive disadvantage.
What "Custom Briefing Requests" Mean
Professional subscribers may request analysis on:
- A specific FDA guidance or enforcement action
- Emerging regulatory themes
- Industry-specific implications
Requests are scoped for:
- • Public information only
- • Intelligence and interpretation, not advice
- • Typical delivery within 3-5 business days
What $497/month Actually Replaces
Consider what you're currently spending—directly or indirectly—on regulatory awareness:
Without Structured Intelligence
- $150-300/hrSenior staff time monitoring FDA sources
- 10+ hrs/weekAggregating, filtering, interpreting updates
- $50K-500K+Cost of a single missed enforcement signal
- WeeksDelayed executive alignment on regulatory shifts
With Nysom360 Professional
- Decision-ready briefs delivered to your inbox
- Pre-interpreted implications for each function
- Custom briefings on emerging issues you identify
- Executive-ready framing for leadership discussions
Bottom line: If your RA/QA lead costs $175/hr, Nysom pays for itself if it saves 3 hours of research time per month.
This is not a news service.
It's decision compression for regulated environments.