Biotech, Pharma & Life Sciences

Built for the science.
Ready for the audit.

As you move from discovery toward IND and clinical work and add pharma partners, GxP, 21 CFR Part 11, and AI-in-validated-systems governance stop being optional. We build the foundation now, so a partner's quality audit becomes a formality instead of a fire drill.

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Why this matters for biotech

Pharma partners audit
before they sign.

A promising molecule does not close a pharma deal on its own. The moment you handle regulated research or clinical data, or you let an AI model touch a GxP record, data integrity and software validation become the thing a partner's quality team examines first. Get it right early and it costs a fraction of retrofitting it under a signed partner's review.

What you need, when and why

The frameworks in your world,
and who owns each.

We deliver this in-house
SOC 2 ISO 27001 ISO 42001 HIPAA

The organizational and AI-management certifications your investors and pharma partners run diligence against. We assess, implement, and deliver these done-for-you, HIPAA where you handle clinical or patient data.

We specify and connect the right partner
GxP (GLP / GCP / GMP) 21 CFR Part 11 Data integrity (ALCOA+)

The validated-systems and data-integrity regimes specific to life sciences. We specify the controls your systems must meet and bring in the right quality and validation partner to execute them.

How the evidence gets built

One control, traced end to end.

Frameworks are abstract until you can see a single requirement turn into the artifact a reviewer actually reads. Here is one, the way it runs through the program.

The control
Every change to a GxP record is attributable, time-stamped, and cannot be altered without a traced, signed reason, including any change an AI model proposes.
Where it is required
21 CFR Part 11 controls for closed systems, GxP data integrity (ALCOA+), and the ISO 42001 control that governs how an AI model may act on a validated record.
The evidence it produces
The audit-trail specification, the access-control matrix, the validation protocol (IQ, OQ, PQ) proving the trail cannot be defeated, and the SOP the reviewer reads. One control, and data integrity is demonstrable rather than asserted.
Who it is for

Built for the companies
turning data into medicine.

AI-driven drug discovery

Platforms using AI to find, design, or optimize compounds, where the research data and the model both carry weight.

Diagnostics and therapeutics

Clinical-stage companies whose data moves from research into regulated, patient-affecting use.

Clinical-stage biotech

Teams approaching IND and clinical trials, where GxP and Part 11 become mandatory to progress.

Tell us where your science is. We will tell you what GxP, Part 11, and your AI governance actually require next.



or start the free scoping questionnaire at ferendis.com/start