Pharma · MedTech

Your team knows the science.
We get it to market.

Novu Insights brings senior-level ownership to every engagement. No junior staff. No handoffs. Just results.

Talk to us about your launch
See what we do
Team members led on global launch programs
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Years in pharma & MedTech
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Products Launched
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The problem we solve

We integrate into your cross-functional team to solve problems and break down silos

Small and mid-size pharma companies rarely have the bandwidth to own a full product launch end-to-end, and decisions are difficult to makewith so many stakeholders.

Most consultancies hand your work to junior staff. We don’t. Every engagement at Novu Insights is led by a director-level expert who has done this before, at scale, for some of the world’s largest pharma companies.
Regulatory staff overwhelmed at launch

Your team has the expertise but not the bandwidth. We embed as a senior extension,  owning workstreams so your team stays focused.

IFU, labeling, and secondary packaging

Normally done by multiple vendors, we bring a complete approach to your needs

No single owner across the full program
Regulatory, design, packaging, and human factors are siloed across vendors. We bring it under one roof with one accountable lead.

The problems we solve

Full-scope. Senior-led. One partner.

Seven capabilities, one accountable team. We cover the full arc from regulatory strategy to market-ready packaging.

IFU writing & design

Instructions for use written to FDA and EU regulatory standards, then designed for clarity and compliance. Content and design under one roof.

FDA 21 CFR

EU MDR
Plain language
Labeling & secondary packaging
Global labeling strategy and execution — from carton and label content to secondary packaging design across multiple markets and languages.
Global markets
Multi-language
Artwork mgmt
Human factors & usability
End-to-end human factors programs — from use-related risk analysis and study design through patient testing and FDA submission support.
IEC 62366
HF studies
Patient testing
FDA readiness & audits
Pre-submission reviews, mock audits, and gap assessments to make sure your documentation and processes are ready before FDA comes knocking.
Pre-submission
Gap analysis
Mock audits
ISO 13485 compliance
Quality management system guidance for medical device manufacturers — from initial implementation through audit readiness and ongoing compliance.
ISO 13485
QMS
Audit prep
Product & program strategy
From feasibility to launch — aligning regulatory, commercial, and operational workstreams so your program hits milestones without surprises.
Launch strategy
Roadmapping
Cross-functional
Project & program management
Senior program leadership embedded in your team — owning timelines, budgets, resource loading, and cross-functional coordination from kickoff to launch.
Global programs
CapEx/OpEx
Resource mgmt

Proven at scale

We've done this. At the highest level.

Not theory. Not templates. Real programs, real launches, real accountability.

Global pharma launch

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

Our team has completed IFU writing, labeling, and secondary packaging for product launches.

Global markets · Multi-language · Top-10 pharma

Program leadership

Global team of 25 from kickoff to launch

Owned the full program timeline, resource loading, and CapEx/OpEx budget for a complex global launch, managing a cross-functional team across multiple markets and functions.

25-person team · Full budget ownership · On time

Human factors

End-to-end HF program for a drug delivery device

Defined device specifications, developed custom testing equipment, and led patient testing through to FDA submission support. 

Drug delivery · Custom test equipment · Patient studies

Who this is for

Built for small and mid-size pharma & MedTech teams

You have the science. You have the team. What you need is a senior partner who can own the programs your team doesn’t have bandwidth for.
  • Pharma companies preparing for first FDA or EU submission
  • Regulatory teams stretched thin at launch
  • MedTech startups who need regulatory + program leadership
  • Companies launching into multiple global markets simultaneously
  • Teams who need IFU, labeling, and packaging under one accountable owner

Who this is for

01

Director-level on every engagement

You work directly with Josh,  not a project coordinator managing junior staff on your behalf.

02
Full scope, one owner

Regulatory, IFU, labeling, packaging, human factors, and program management,  no vendor juggling.

03
Built for speed
We move at startup pace without sacrificing compliance rigor. Tight timelines are our normal.
04
Embedded, not external

We work like we’re on your team, in your tools, on your calls, accountable to your milestones.

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

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