Build with quality. Prepare with confidence.

We help pharmaceutical facilities assess their GxP compliance, address gaps and prepare for regulatory inspections. Our support brings together facility assessments, quality system review, documentation readiness and practical remediation planning.

Inspection readiness for your target market

US FDA | MHRA | EMA / EU GMP | MFDS | SFDA | ANVISA | TGA | Health Canada | TFDA | Other markets on request

Before the inspection

• GxP gap assessments, internal audits and mock inspections
• Review of manufacturing, QC, utilities and quality systems
• Data integrity, validation and documentation readiness
• Action plans and employee preparation

During the inspection

• Site team preparation and inspection coordination
• Document retrieval and response support
• Technical review of information requested by inspectors

After the inspection

• Observation assessment and investigation support
• Preparation and review of inspection responses
• CAPA development, remediation and effectiveness review
• Follow-up against agreed corrective actions

Deliverables: A documented assessment, audit observations and a prioritized action plan, with response and CAPA support as agreed.

We conduct vendor audits for API, excipient and packaging suppliers, contract manufacturers and testing laboratories. Each assignment follows an agreed scope, from document review and audit planning to site assessment, reporting and CAPA follow-up. Quality agreement review and supplier qualification support are included where required.

We provide Permitted Daily Exposure (PDE) reports for pharmaceutical substances to support health-based exposure limit assessments, cleaning validation and cross-contamination control in shared facilities.

• Review of available substance-specific toxicological and pharmacological data
• Evaluation of critical effects and derivation of the PDE with a documented scientific rationale
• Traceable references, assumptions and assessment conclusions
• Technical clarification to support use of the report in your quality system

Deliverable: A substance-specific PDE assessment report.

We provide pharmaceutical facility design and construction services aligned with applicable GxP requirements, covering general, potent and oncology facilities. Our scope connects design, project execution, qualification and operational readiness.

• Concept layouts and detailed design review
• Personnel, material and waste flows; zoning and segregation
• Cleanroom finishes, HVAC, utilities, cleaning access and containment requirements
• Construction planning and execution, project coordination and quality oversight
• URS and design qualification documentation
• Commissioning, qualification and handover documentation support

Project focus: A facility designed and constructed around its intended processes, product risks and applicable GxP requirements.