The questions people actually ask

Diagnostics are fixed-fee and quoted before the site visit, so the cost of finding out is known in advance. Remediation is fixed-scope against the diagnostic register. Retained support under Compliance as a Service is priced on an agreed number of days per month.

We do not quote a day rate before a diagnosis, because a number produced before the problem is understood is a guess with a decimal point in it.

No. If you already know what the problem is, for example a specific finding to close or a validation package to write, we can go straight to the work. The diagnostic exists for the more common situation: you know something is wrong, and the argument inside the business is about which thing to fix first.

For an urgent situation — an inspection date, a critical finding, a data integrity issue — tell us on the first call and we will say honestly what we can do and by when. Scheduled work typically starts within two to four weeks. Retained support starts at the beginning of a month.

We draft with your team rather than for them. A procedure written entirely by an outsider tends to describe an idealised site, and it stops being followed the month after the consultant leaves. Where capacity is genuinely the constraint we will do the drafting, but your people review, own and sign it.

No. Batch certification and release decisions stay with your QP. We support the QP, prepare the evidence the decision rests on, and improve the path that gets a batch to that decision faster. We do not take the decision.

None of the three. We are an independent advisory. Nothing we issue is a certificate, a licence or a regulatory approval, and an inspection outcome is never something a consultant can guarantee. What we can do is make the outcome far less dependent on luck.

Both. Facility assessments, mock inspections and supplier audits are materially better on site, and we will say so when remote work would produce a weaker result. Documentation work, validation review, dossier updates and management review preparation run well remotely. Engagements run in English and Dutch.

Fractional quality capability: an agreed number of days each month, drawn from a group of consultants rather than a single person, with one named lead who holds the site knowledge and stays constant.

It suits sites that need a validation specialist, a data integrity reviewer, an auditor and a QP-level reviewer, but not any one of them full time.

A mutual non-disclosure agreement is signed before any site-specific information is exchanged, including before a diagnostic. We do not name clients publicly without written permission, and case material is only ever published anonymised and with consent.

No. No software resale, no vendor commissions, no certification body affiliations. If we recommend a system, we have no financial interest in which one you choose.

No. It is a structured self-assessment that reflects what you report about your own system. It is not an audit, not a regulatory determination, and it produces no certificate. A low score does not mean you are non-compliant, and a high one does not guarantee an inspection outcome. It is a way of finding out which two areas deserve attention first.

They come from you. Every rate in the model is a visible default that you replace with your own figures, and the arithmetic behind each line is stated on the page. It models costs you are already carrying — investigation hours, CAPA oversight, working capital in held batches — rather than predicting a recall or a regulatory action. It is a planning aid, not financial advice.

You keep everything: the register, the documents, the data and the rationale behind each decision. The verification step exists precisely so that the improvement survives our departure, and if you would rather not retain us for it, we will tell you what to check yourself and when.