Ensuring Compliance with GxP Standards in Clinical Trials

Running First-in-Human (FiH) trials isn’t just about hitting scientific milestones — it’s about doing it under tight timelines, limited resources, and a mountain of regulatory expectations. And somewhere between protocol drafts and CRO calls, compliance has to happen.

But what does “compliance” actually mean at this stage?

In our experience: clarity, structure, and a system that’s easy to live with. Preferably one that doesn’t live exclusively in someone’s inbox.

A System You’ll Actually Use

At OZQA, we work with early-stage biotech and medtech companies to help them build quality systems that are inspection-ready — without overengineering things.

We focus on:

• GxP essentials: Documentation, processes, roles, training

• Phase-appropriate SOPs: Tailored for FiH, with action lists that are actually usable

• Flexible structure: Works whether you archive on paper or store everything digitally and encrypted

No fuss. Just tools that make sense.

Not Every QMS Needs a Software Subscription

One of the things we hear most often is:

“We don’t have a system.”

Our answer?

If you’re documenting your work in any way — even in a shared folder or a binder — you do.

The question is whether it’s:

• Structured

• Version-controlled

• And defensible in front of an inspector

That’s where we come in. Our QMS setup can be applied just as easily to paper-based workflows as to digital environments — so you don’t have to invest in an eQMS before you’re ready for one.

Built for Speed (And Sanity)

We know early trials move fast. That’s why our approach is designed to deliver:

• A fully operational QMS in weeks, not months

• 15 hours of expert guidance to get your team up to speed

• Support that sticks — from initial setup to final signature

Because let’s face it: no one wants to be figuring out their CAPA process the week before an inspection.

One Step Ahead of the Regulator

GxP compliance doesn’t have to slow you down. In fact, when it’s done right, it gives you the confidence to move faster — because you’re not second-guessing your foundation.

If you're planning or running a First-in-Human study and want to stay focused on the science without losing track of compliance, you're not alone. We're here to help you navigate it — simply, clearly, and without panic.