Quality Through the Phases: A Survival Guide for Biotech Teams

Let’s be honest. When you start a biotech company, you’re probably thinking about molecules, milestones and maybe money — not whether your SOPs are version-controlled or if your training logs are audit-proof.

But somewhere between your first data set and your first patient dose, you realise:

👉 Quality isn’t optional.

👉 And compliance doesn’t care if you’re understaffed.

To help you make sense of it all, we’ve broken down what “quality” really means — not in the abstract, but phase by phase. Scroll down for the visual version if you’re more of a diagram person.

Preclinical Phase – “The Calm Before the Audit”

In the preclinical world, things are still manageable. There are no inspectors banging on the door (yet), and your main job is to generate clean, credible data. Sounds simple?

Well… only if you’ve got your documentation in order.

At this stage, quality means:

• Making sure your raw data doesn’t disappear with someone’s laptop

• Having processes that someone else (not just you) could follow

• Not naming your SOPs things like “final_FINAL_use_this_one.pdf”

It’s about building habits now that your future self will thank you for. Or at least, not curse you over.

Phase I/II – “Congratulations, Now You’re Accountable”

Welcome to the grown-up table.

Once you’re in human trials, regulators take a much keener interest in your operations — even if you’ve outsourced everything to a CRO. Here’s the kicker:

You can delegate tasks. You cannot delegate responsibility.

At this stage, you’ll need to show:

• That you understand who’s doing what — and why

• That deviations are tracked, not buried

• That your quality system exists outside of your inbox

Oh, and that someone besides you knows where the signed contracts live.

(It’s always fun when an inspector asks for a supplier agreement and you have to message someone on vacation.)

Phase III – “So, About That Audit…”

By now, your quality system should be less of a patchwork and more of a structure.

In Phase III, authorities (and potential partners) expect maturity:

• Consistent documentation

• Formal change control processes

• Training records that don’t live on post-its

If you’re planning to license, raise capital or move toward marketing authorisation, your QMS will be under the microscope — possibly literally.

Think of it like this: quality is no longer a “function.” It’s part of your reputation.

The Big Picture

The image below shows a simplified journey through the product lifecycle, and how quality systems evolve alongside it. Each coloured box highlights key quality activities you’ll need to consider — from early documentation to post-marketing oversight.

Credit: RightQA.dk

The takeaway?

You don’t need to do everything at once. But you do need to know when to do what — and why it matters.

Because if there’s one thing quality doesn’t like, it’s guesswork.