Question 1

How is the Custom Solution different from buying separate single-standard engagements?

Accepted Answer

Separate engagements cover each standard well within its own boundary. They do not cover the intersections: the GACP-GMP handoff at plant material receipt, the Annex 11 requirements that apply to ISO 17025 laboratory systems, the ICH Q10 elements that should align with ISO 9001 structure. The Custom Solution makes one team accountable for the standards and the intersections between them. This is structural, not commercial.

Question 2

What does the initial assessment actually produce?

Accepted Answer

A gap map by standard with severity ratings (major, minor, observation). An intersection risk assessment covering each pair of applicable standards. A priority matrix sequencing remediation by risk exposure. A preliminary programme scope with module breakdown and a realistic timeline estimate. The output is concrete enough that you can use it to brief an internal team or compare alternative providers.

Question 3

Can you work alongside our existing consultants?

Accepted Answer

Yes. Many engagements start with existing consultants in place for one or two standards. We define the boundary clearly, take responsibility for the integration layer and the intersection risks, and produce a shared work plan. Where existing arrangements work, we preserve them. Where they produce gaps at intersections, we address those gaps with explicit accountability.

Question 4

Can you guarantee certification or inspection outcomes?

Accepted Answer

No, and any consultant who claims otherwise should be treated with caution. We can prepare your operation to a documented standard of readiness, support the audit or inspection itself, and manage any findings through to closure. The final decision rests with the certification body or competent authority. What we guarantee is methodology, transparency, and a measurable state of readiness at programme close.

Question 5

How long does a full Custom Solution programme take?

Accepted Answer

It depends on starting state, scope, and operational capacity to absorb change. Greenfield programmes covering GACP, EU-GMP and ISO simultaneously typically run 12 to 18 months to first certification readiness. Consolidation programmes for operators with partial systems often complete in 6 to 10 months. M&A due diligence assessments deliver in 5 to 15 working days. The assessment phase produces a realistic timeline before any execution commitment.

Question 6

What does intersection risk mean in practice?

Accepted Answer

A concrete example: dried plant material moves from a GACP-compliant cultivation site to a GMP-compliant production facility. GACP governs cultivation and harvest. GMP governs production. The receipt point belongs to both. If the GACP traceability records do not match the GMP batch record format, both sides look compliant in isolation while the handoff produces a finding. Intersection risk is structural, not procedural, and it is invisible until somebody audits across the boundary.

Question 7

How is the programme priced?

Accepted Answer

The assessment has a fixed cost defined before any work begins. The programme proposal that follows is priced by module and phase, so you only commit to what you actually need. There is no retainer model and no open-ended engagement. Each module has defined deliverables, completion criteria, and a fixed budget. Scope changes are handled through explicit change orders, not silent cost expansion.

Question 8

What happens at programme close. Does our team operate independently?

Accepted Answer

Yes. Knowledge transfer is a defined stage, not a closing courtesy. Procedures, training materials, SOPs, system documentation and audit programmes are fully owned by your team. Your internal personnel are trained to operate the system, conduct internal audits, and respond to surveillance audits independently. Continued advisory access remains available on demand but is not designed-in dependence.

Question 9

Do you offer multi-standard due diligence as a standalone service for investors?

Accepted Answer

Yes. The investor and M&A use case is a distinct offering. The output is an independent technical assessment across applicable standards with prioritised remediation roadmap and indicative cost estimates per finding. The engagement is structured to be independent of any subsequent implementation work, so the assessment maintains its integrity as a due diligence artefact.

Question 10

How do we get started?

Accepted Answer

Use the form below to request an initial assessment. We respond within 24 business hours to schedule a 30 to 45 minute strategic call. The call is an assessment conversation, not a sales pitch. If the situation fits a Custom Solution, we propose a structured assessment scope and fixed cost. If a single-service engagement is sufficient, we tell you and point you to the right page.

One compliance programme. Multiple standards. One team.

Does this describe your operation?

The spaces between standards are where findings happen.

Three engagements. Three integration patterns.

A programme built on your assessment.

Five areas that can be integrated in your programme.

Five stages from first assessment to independent operation.

Which situation describes yours?

Multi-specialist team. Verifiable credentials. Measurable programme KPIs.

Understand your multi-standard compliance picture before we talk.

Multi-standard integration guide

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Questions about the Custom Solution.

Start with the assessment. Everything else follows from it.