Schedule a Call
Schedule a Call

THE SENIOR EXPERT YOUR TEAM NEEDS
WITHOUT THE FULL-TIME HIRE

From FDA submissions and global packaging programs to AI-powered revenue forecasting — Novu Insights brings 15+ years of senior-level expertise to the healthcare and business intelligence challenges that can’t afford to go wrong.

See how we can help
See what we do
Years in MedTech & Pharma
0 +
Products commercialized
0 +
Team members led globally
0 +

FDA &
EU

Regulatory coverage
Pharma & MedTech
Regulatory, IFU, Packaging & Program Leadership
Senior-led regulatory strategy, IFU writing, labeling, packaging, and human factors — from first submission to global launch.

FDA Readiness

IFU & Labeling
ISO 13485
Human Factors
Explore Pharma & MedTech →

AI Transformation

Revenue Intelligence & Business Decision Support

AI-native analysis across your finance, ops, and CRM data — turning fragmented signals into forecasts leadership can act on.

Revenue Forecasting

Deal Flow

Data Strategy

AI Implementation

Explore AI Analytics →

What brings you here?

Two practices.
One senior partner.

Whether you’re navigating a regulatory submission or trying to make sense of your business data — we’ve built a focused practice around each. Select the one that fits your situation.
Pharma · MedTech · Regulatory
Getting your product to market —
compliantly, on time, and without surprises.
IFU writing and design, labeling and secondary packaging, human factors studies, FDA readiness, ISO 13485 compliance, and program management — all under one senior-led roof. Built for small and mid-size pharma companies and MedTech teams who need expert bandwidth at launch.

IFU & Labeling

Regulatory & Audits
Human Factors
Program Management
Packaging
Explore Pharma & MedTech →

Business Intelligence · AI Analytics · Growth

Turning your data into the revenue, margin, and operational clarity you’re leaving on the table.
AI-native analysis across your finance, operations, and CRM data — surfacing reorder trends, forecasting revenue, modeling scenarios, and putting decision-ready intelligence in front of leadership. For any industry, on an ongoing embedded basis.

Revenue Forecasting

Deal Flow
Data Strategy

Decision Support

AI Implementation

Executive Narratives
Explore AI Analytics →

Not sure which fits your situation — or think you need both? That’s a common starting point. Tell us what you’re working on and we’ll point you in the right direction.

Start with a conversation →

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 — at top-10 pharma companies, global product launches, and complex data environments.

15+ yrs MedTech & Pharma

Top-10 Pharma

FDA · EU MDR · ISO 13485
Global launch programs
AI-native analytics

01

Senior-led, always

You work directly with the expert — not an account manager or junior analyst. The person with 15+ years of experience is the person doing your work.

02
Full scope, one owner

Regulatory submissions, IFU design, packaging, human factors, data analytics, program management — one accountable partner across everything.

03
Embedded, not episodic
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.

04

Built for speed
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.

A sample of what senior-level ownership actually looks like across both practices.

Global pharma launch

Full labeling & packaging program for a top-10 pharma company

Led all IFU writing, labeling strategy, and secondary packaging design for a successful global product launch — managing a cross-functional team of 25 across markets, timelines, and a full CapEx/OpEx budget.
25-person team · Global markets · Top-10 pharma · On time
Human factors
End-to-end HF program for a drug delivery device
Defined device specifications, built custom testing equipment, and led patient testing through to FDA submission support — full ownership from study design to results.
Drug delivery · HF study design · Patient testing · FDA support

Revenue intelligence

12-month rolling forecast built from finance, ops, and CRM
Connected three disconnected data sources, uncovered reorder trends, modeled win/loss rates at the customer level, and delivered a 12-month rolling revenue and deal flow forecast leadership could act on immediately.

Finance · CRM · Operations · 12-month forecast · Deal flow

Contact us for detailed case studies →

15+ years of experience working with

Pfizer
Amgen
Roche
Takeda
Merck
Palmer Wellness
Winding Lane
Orlando Health
Advent Health
Novo Nordisk

Let’s talk

Not sure where to start?
Start with a conversation.

Tell us what you’re working on — a submission, a launch, a data problem, or something that doesn’t fit a neat category. We’ll tell you honestly whether we’re the right fit and what we’d do about it.

Schedule a free intro call
No pitch. No pressure. 30 minutes to figure out if it’s worth going further.

or email jhopkins@novuinsights.com

© 2026 Novu Insights · All rights reserved
Scroll to Top