Pre-approval and routine
Audit and inspection preparation
We audit you the way a regulator would, then help you close the gaps and prepare your people to speak for their systems.
Discuss your programmeOverview
Inspections go wrong in predictable ways: records that cannot be found, staff who guess, and systems that look different on paper than on the floor.
We run realistic mock inspections, give you a prioritised list of what to fix and coach the team that will face the inspector, in the front room and the back room.
What we do
Mock inspections
A multi-day exercise run to the format of the target authority, with a written report ranked by risk.
Supplier and CDMO audits
Qualification and for-cause audits of manufacturers, testing labs and critical material suppliers, with a clear accept, conditional or reject recommendation.
Data integrity assessments
Review of electronic systems, audit trails, laboratory records and paper controls against ALCOA+ principles.
Inspection readiness programmes
Roles, logistics, document retrieval, storyboards and rehearsed question handling, so the team is calm on the day.
Response writing
Structured responses to Form 483 observations, warning letters and audit findings, with corrective actions that regulators accept.
Quality system gap assessment
A phase-appropriate view of where your quality management system stands, and what to build next.
When teams call us
- A pre-approval inspection has been announced.
- Your CDMO is about to host a regulator on your behalf.
- You received observations and need a response that is complete and credible.
- You are qualifying a new supplier and need an independent view.
How it runs
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Scope and agenda
We agree the systems, sites and standards to be audited and the format of the exercise.
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Audit
We carry out the audit on site or remotely, working from records, interviews and observation.
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Report and prioritise
You receive a written report that ranks findings by risk and suggests an order of work.
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Coach and close
We rehearse your team, help with corrective actions and re-check the points that matter most.
Common questions
Tell us what you are facing
A thirty-minute scoping call, no charge. We will tell you honestly whether we are the right team.