Services

Regulators demand proof that every system behind a medicine is trustworthy. DQA makes that proof a competitive advantage — not a bottleneck.

AI/ML System Validation

Bring GxP-grade rigour to AI and machine learning systems entering regulated environments – a fast-moving area most consultancies haven’t caught up with yet.

Clinical Trial Systems Validation

Validate EDC, IRT, CTMS, safety databases and ePRO platforms to GCP standard, with one expert who understands the trial as well as the technology.

Computer System Validation & CSA

Validate the systems your trials and manufacturing depend on – built and audited by consultants who’ve implemented them from the inside, not just reviewed them on paper.

Data Integrity

Assess and strengthen the trustworthiness of the data behind every regulatory submission – from source system to final report.

GxP Auditing

Independent, senior-led audits that find what actually matters – gaps that would stop an inspection in its tracks, not just paperwork tidiness.

Merger, Acquisitions & Due Diligence Support

Give acquirers and investors a clear-eyed view of quality and compliance risk before the deal closes, not after.

Pharmacovigilance (PV) & GVP

Build and audit the safety monitoring systems behind your medicines – from signal detection to periodic safety reporting – held to the same standard as the rest of your quality system.

Prepare for Inspections

Coach organisations so they are completely ready and confident when regulators like the FDA or MHRA arrive to examine their practices.

Quality Documentation & SOPs

Build documentation that holds up under scrutiny and reflects how your organisation genuinely operates, not a generic template bolted onto your processes.

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Who we work with

Have a defined scope - or a challenge with no obvious solution?

Whether you need a targeted audit, a CSV programme from scratch, or a conversation about where Al fits in your validated environment, the DQA Way starts here.