WE HELP BUSINESSES
GROW
LAUNCH PRODUCTS
& IMPLEMENT AI
Novu Insights brings 15+ years of senior-level expertise to Pharma, MedTech, and Al Implementation projects over startups, small businesses, and global corporations
FDA &
EU
Program, Product, IFU, and Secondary Packaging Development
AI Transformation
AI Automation, Strategy, Training, and Business Intelligence
AI-native analysis across your finance, ops, and CRM data, turning fragmented signals into forecasts leadership can act on.
Revenue Forecasting
Strategy
AI Implementation
What brings you here?
Grow. Launch. Integrate
One senior partner.
Whether you’re navigating a regulatory submission or trying to make sense of your business data, we’re here to help. Select the one that fits your situation.
Getting your product to market on time, on budget, and without surprises.
We lead IFU writing and design, labeling and secondary packaging, human factors studies, FDA readiness, ISO 13485 compliance, and program management.
Built for small and mid-size pharma companies and MedTech teams who need expert bandwidth at launch.
IFU & Labeling
Business Intelligence · AI Analytics · Growth
AI-native analysis across your finance, operations, and CRM data.
We can surface reorder trends, forecast revenue, model scenarios, and put decision-ready intelligence in front of leadership.
For any industry, on an ongoing embedded basis.
Revenue Forecasting
Decision Support
AI Implementation
Not sure which fits your situation? That’s a common starting point. Tell us what you’re working on and we’ll point you in the right direction.
Why Novu Insights
The expertise of a large firm.
Without the large firm problems.
Big regulatory agencies and consulting firms bill your work to junior staff, move slowly, and charge accordingly. Every Novu Insights engagement is led directly by a director-level expert with real experience.
15+ yrs MedTech & Pharma
Top-10 Pharma
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Senior-led, always
You work directly with our experts, not an account manager or junior analyst. The person with 15+ years of experience is the person doing your work.
Regulatory submissions, IFU design, packaging, human factors, data analytics, program management.
We work inside your business, in your tools, on your timelines, accountable to your milestones. Not a vendor who shows up for a deliverable and disappears.
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Whether it’s a tight submission window or a leadership team waiting on a forecast, we move at the pace your business needs without sacrificing rigor.
Proven in practice
Work that speaks for itself.
Global pharma launch
Full labeling & packaging program for a top-10 pharma company
25-person team · Global markets · Top-10 pharma
Defined device specifications, built custom testing equipment, and led human factors strategy through to FDA submission support.
Revenue intelligence
Finance · CRM · Operations · 12-month forecast · Deal flow
15+ years of experience working with