If you’re building a life science company, you know the feeling: every new product you develop, every new market you plan to enter and every new regulation that gets launched adds another layer of compliance complexity.

What started as a manageable set of requirements suddenly turns into a maze of overlapping standards, week-long audits, and endless spreadsheets.

Instead of enabling your growth in a regulated industry, compliance starts to feel like it’s holding you back.

At Qualio, we think it should be the opposite.

Compliance should give you the confidence to move faster — not slow you down.

That’s why we built Compliance Intelligence, our new AI-powered platform designed to make continuous audit readiness not just possible, but natural and automatic.

Why compliance is harder than ever

The bar has never been higher for life science companies.

Warning letters have increased by 43% since 2019.

And pioneer medical devices face, on average, 7 months of market delay from compliance setbacks.

Today’s growth-stage medtech and biotech companies face some tough challenges:

• Expanding product portfolios bring new audits, each with different requirements

• Global regulations are multiplying. ISO 13485, ISO 27001, the EU MDR, the FDA's new QMSR, the EU AI Act… the list keeps on growing

• Manual, consultant-heavy compliance processes can’t keep pace with agile release cycles, or the increasingly nimble, tech-driven nature of life science. And they're expensive!

If you get compliance wrong?

Rejected or delayed approvals. Multi-million-dollar fines. Or product recalls that damage your reputation for years.

So we asked ourselves: what if compliance could keep up with modern life science innovation?

Introducing Compliance Intelligence

Compliance Intelligence transforms your compliance processes from a bottleneck into a growth accelerator.

Here’s how:

• Be audit-ready in weeks, not months. Our AI-powered gap analysis scans your quality system and delivers a complete assessment in just 30-40 minutes. Armed with pinpoint knowledge of every compliance gap, users cut audit prep from 20+ weeks to less than 4.

• Eliminate audit surprises. Real-time dashboards and predictive alerts catch risks before your auditors do, letting you nip problems in the bud. No more post-audit response plans, CAPA panic stations, or regulatory punishments.

• Do more with the team you have. Automated workflows and evidence reuse eliminate hundreds of hours of manual evidence gathering and analysis. And with in-house, AI-powered regulatory expertise, users lower consultant spend by hundreds of thousands of dollars per year.

• Access one platform for all your standards. With expert-built, pre-validated frameworks for regulatory standards from ISO 13485 and GMP to electronic signature and record requirements, you can unify your compliance in a single system and reuse evidence across multiple frameworks.

“Everything Compliance Intelligence does to identify gaps, and to make us more productive and speedy in resolving them, reduces our risk.

It’s going to be part of the state-of-the-art tools we need in companies to make sure compliance gaps and audit risks are handled.”

— Christophe Dohr, Site Quality Manager, Sentec

Real-world results

Early adopters of Compliance Intelligence are already seeing transformative outcomes:

• 5× faster audit readiness: Reducing prep time from 20-24 weeks to just 4.

• 60–75% faster market entry: Cutting market expansion timelines from 9 months to as little as 3.

• $150K–$300K annual consultant savings: Redirecting budget from audit prep to value-add activities like R&D and market growth.

• Fewer disruptions: Preventing last-minute fire drills that pull engineering and clinical teams from their core work.

These results aren’t theoretical. They’re happening right now in companies operating under the most stringent regulations on the planet.

Built for life sciences — not adapted for it

Unlike generic AI tools, Compliance Intelligence is purpose-built for the regulatory realities of life sciences.

It's grounded in frameworks that are created by our in-house compliance experts, then independently reviewed and validated by third-party quality and regulatory professionals with proven FDA experience.

And because it connects with your existing tools, evidence gathering fits seamlessly into your workflows.

The result? Compliance stops being a 'black box', and becomes something you can measure, manage and report on with clarity.

"With this tool, the painful and time-consuming process of gap analysis is gone.

And because you’re cutting the risk of audit findings in the first place, the pain of having to resolve things afterwards is gone too.”

— Albert Rodriguez, FDA inspector & regulatory consultant

Q&A

We teased Compliance Intelligence at a number of recent webinars, and took note of questions and queries from the audience.

Here were the most common:

The bottom line

With Compliance Intelligence, you don’t just get through your next audit.

You build a foundation of continuous, confident compliance that scales with your company.

That means no more last-minute fire drills.

No more lost weekends pulling evidence together.

No more wondering if you’re really ready.

Just the confidence to focus on what matters: bringing new products to market, and improving lives.