Three fixed-scope engagements for organisations that need a senior, independent view now, without a retainer, a long procurement process, or committing to a full programme up front.
Not every requirement needs a full validation programme or a retainer from day one. Sometimes the immediate need is narrower: a second opinion on a document before it goes to Quality, a clear-headed assessment of a stalled position, or an independent view on a specific compliance question.
These three engagements are scoped tightly enough to start quickly and deliver a defined outcome, and they stand on their own whether or not any further work follows.
A focused review of one defined compliance or validation issue, where the situation is not yet clear enough to know what the right next step is.
Suitable for: a disputed requirement, a document or decision awaiting approval, an initial response to an audit observation, or deciding whether a larger assessment is justified.
Includes: a focused review meeting, examination of the specific issue or document, identification of the material risks, and a short prioritised summary with a recommended next step.
A senior, independent review of a single validation, Quality or supplier document before it goes forward for approval or submission.
Suitable for: validation plans and reports, URS and risk assessments, Part 11/Annex 11 assessments, supplier assessments, SOPs, CAPA responses, traceability matrices and audit responses.
Includes: annotated review comments, prioritised findings, identification of gaps and unsupported claims, and a short call to walk through the findings.
A structured engagement to reset an incomplete, delayed or disputed validation position onto a defensible, risk-based footing.
Suitable for: an approaching go-live, rejected validation documentation, incomplete traceability, weak supplier evidence, or a programme stalled by validation uncertainty.
Includes: review of the current position, a stakeholder working session, identification of critical and lower-priority gaps, and a written, prioritised recovery plan.
Scope and fee are confirmed directly for each engagement, based on the specific document, system or deadline involved. This keeps the fee proportionate to the actual work, rather than a flat rate that overcharges simple cases and underscopes complex ones.
Send a brief description of the system, document or issue through the contact form, selecting "Focused Engagement".
A short call or written exchange to confirm this is the right starting point, and to agree scope, fee and timeline in writing.
Once scope and payment terms are agreed and the required material is received.
In the agreed format, with a short call to walk through the findings and the recommended next step.
These are independent, evidence-based reviews, scoped to the material made available. They do not constitute regulatory approval, certification, or legal advice. Where full remediation or implementation support is required beyond the agreed scope, this is confirmed and quoted separately.
Describe the system, document or deadline involved, and the right starting point will be confirmed directly, including whether a Focused Engagement is the right fit at all.