Level 1
Assessment
“Where are you now?”
An independent picture of your regulatory and quality position, ranked by risk.
- Requirements review
- GMP and QMS gap assessment
- Readiness audits
- Prioritised findings report
Our approach
Assess. Develop. Implement. Improve.
A repeatable pathway from an unclear regulatory position to an inspection-ready quality system.
01The pathway
Seven stages, every engagement
Each stage produces something concrete — a report, a document set, a trained team, an audit record.
Scroll the pathway →
02A worked example
A manufacturer entering a new market
A manufacturer entering a new market follows the sequence on the right. Every step is documented, so you always know which stage you are in.
It scales down for a distributor or a start-up facility — fewer documents, the same discipline.
- 01Assess the applicable regulatory requirements.
- 02Review the client's current Quality Management System.
- 03Perform a regulatory / GMP gap assessment.
- 04Develop the required SOPs and quality documents.
- 05Train personnel.
- 06Support implementation.
- 07Conduct an internal audit.
- 08Help the client prepare for regulatory inspection.
- 09Support corrective actions.
- 10Continue with periodic compliance monitoring.
03Our business model
Three levels of engagement
A programme, not a one-off project.
Level 2
Implementation
“How do you become compliant?”
We build and install what the assessment found — documents, systems, training and support.
- SOP and QMS development
- CAPA and documentation
- Personnel training
- Hands-on implementation
Level 3
Maintenance
“How do you stay compliant?”
A standing relationship that keeps you current as regulations and your operation change.
- Periodic audits
- Regulatory updates
- KPI monitoring
- Inspection readiness
04Documentation
The document hierarchy we help you build
From quality policy down to the records that prove the work happened.
Quality Manual
Tier 1 — Strategic direction
Describes the structure of the whole quality system, its objectives and scope, and how processes interact. The master reference for how quality is governed.
Quality Policy
Tier 1 — Strategic direction
A leadership-endorsed statement of commitment to quality. It sets the direction every other document follows.
Standard Operating Procedures
Tier 2 — Operational detail
Step-by-step instructions for quality-critical tasks, so document control, deviations and change control are performed the same way whoever performs them.
Work Instructions
Tier 2 — Operational detail
Task-level detail: how to operate a piece of equipment or execute a single step within an SOP.
Records and Forms
Tier 3 — Objective evidence
The evidence generated as work happens — checklists, logs, test results, training records. The basis for audits, CAPA and inspections.
We help you build and maintain the full hierarchy — the basis of an audit-ready quality system.
Start at stage one
You cannot fix what you have not measured.
Begin with an assessment.