Scoped by exposure, not by hours
Every engagement names the risk it removes before it names a price. If we cannot describe what an inspector would find without the work, we should not be selling it to you.
Frameworks: EU GMP Part I & II, Annexes 1, 11, 15, 16; ICH Q7 to Q10; ISO 13485; EU MDR.
Engagements run in English and Dutch, on site across the Netherlands and Belgium, or remotely where the work genuinely permits it.
How an engagement runs
Orientation call
Sixty minutes. Site profile, product types, regulatory history, what triggered the call. We tell you plainly whether the problem needs an outside party at all. Roughly a third of these calls end with advice and no proposal.
Diagnostic
Two to five days on site and in your records. Produces a ranked gap register: each item carries a regulatory reference, an exposure rating, an effort estimate and a named owner, plus a one-page summary for people who will never read the register.
Remediation
We close the top-ranked gaps with your team, not instead of them. Documents are drafted to be maintained by the people who will maintain them. Scope, deliverables and end date are fixed at the start.
Verification
Effectiveness checks, a follow-up mock inspection, or a quarterly review of trend data. This is the step most sites skip, and it is the step that decides whether the previous three held.
The full capability list
GMP gap assessment
Facility, documentation and process reviewed against the framework that governs your market, delivered as a prioritised remediation plan rather than an undifferentiated finding list.
Read moreSystemsQuality management system design
SOP architecture, batch records, change control, deviation and CAPA workflow, document lifecycle. Built to survive staff turnover.
Read moreExposureInspection readiness & mock audits
Inspection run at inspection pace: retrieval timing, back-room function, SME questioning, narrative consistency across departments.
Read moreRecoveryCAPA backlog & deviation recovery
Triage by regulatory exposure, close what can be closed, restructure what cannot, then repair the intake process that produced the backlog.
Read moreEvidenceValidation & qualification
URS through IQ/OQ/PQ, cleaning and process validation lifecycle, computerised system validation and Annex 11 data integrity review.
Read moreSterileAnnex 1 contamination control strategy
CCS authoring and review, aseptic process assessment, environmental monitoring programme design and trend interpretation.
Read moreSupply chainSupplier & CMO audits
API, excipient and contract manufacturer audits, on site or remote, with quality agreement review and follow-up verification.
Read moreGovernanceManagement review support
We prepare and chair management review as a decision meeting rather than a reporting one: one evidence pack covering quality metrics, deviations, complaints, audits and CAPA status, a short list of choices that need funding or headcount, and actions tracked into the next review.
Read moreRetainedCompliance as a Service
Fractional quality capability for sites that need several specialisms but none of them full time. An agreed number of days per month, drawn from a group of consultants rather than one person, with a single named lead who holds the site knowledge.
Read morePerformanceBatch release, PQR and audit programme
Release cycle time, product quality reviews delivered on schedule, audit plan adherence, and quality support for new product introductions and technical transfers.
Read moreCapabilityRole-based GMP training
Built from your SOPs and your deviation history, for operators, QA and management, including data integrity and inspection-behaviour training.
Read moreWe build the solution with your quality team, not for them
Most GMP problems do not have an off-the-shelf answer, because the constraint is never only regulatory. It is a site with this many people, this much shopfloor literacy, this equipment, this customer base and this budget. A solution that ignores any of those is a solution that gets abandoned in month three.
So we design with your quality team: the workflow, the documentation set, the review path, the trending, the training that makes it stick. Your people shape it because your people will run it long after we have gone.
We speak your quality system
Deviations, CAPA, validation, change control, release. No translation layer between what you describe and what gets designed.
And the language that funds it
We have sat in the sales and commercial conversation as well as the quality one. That is why the business case comes with the proposal rather than after it.
Built with the people who own it
Workshops with your team rather than a delivered document set. Ownership is the mechanism, not a courtesy.
It has to survive an inspection
Every custom solution is designed to be explained to an inspector by the person operating it, not only by its author.
A deviation and CAPA workflow that a lean team can genuinely run. A batch record set that reduces error at the line rather than adding signatures. A release path with the waiting designed out of it. A contamination control strategy written as a strategy. A quality metrics pack that a management review can actually decide from. A supplier qualification programme proportionate to what each supplier can do to you.
How we price
Diagnostics are fixed-fee, so you know the cost of finding out. Remediation is fixed-scope against the diagnostic register, so scope creep is a conversation rather than an invoice. Where a site prefers day rates for ongoing support, that is available too, but never as the entry point, because a day rate quoted before a diagnosis is a guess with a decimal point.
Fixed
Diagnostic fee agreed before the site visit.
Ranked
Every finding carries an exposure rating and an effort estimate.
Independent
No software resale, no vendor commissions, no lock-in.
Book an orientation call
Sixty minutes, no proposal attached. Roughly a third of these calls end with advice and nothing else.