1. Inspection Readiness / Mock Inspections

Structured, ongoing preparation for health authority inspections.

Deliverables
• Gap assessment of systems and documentation
• Mock inspection with findings report
• Staff training for inspection day
• Prioritized pre-inspection action plan

2. Risk Assessment

Integral, preventive evaluation of the quality system, aimed at anticipating potential risks before they become a finding or an incident.

Deliverables
• Risk mapping by process/area of the quality system
• Risk prioritization by likelihood and impact
• Preventive mitigation plan
• Risk report to support decisions (suppliers, launch, market access negotiation)

3. Supplier Due Diligence

Comprehensive evaluation of a supplier, site, or CMO ahead of a business decision.

Deliverables
• Documentary and/or on-site audit of the candidate facility
• Review of regulatory compliance history
• Risk report with go/no-go recommendation

4. CMO/Supplier Qualification and Monitoring

Recurring oversight service for the external manufacturing relationship over time.

Deliverables
• Initial supplier qualification program
• Periodic follow-up audits
• Supplier quality performance scorecard

5. QMS / Quality Compliance

Design, redesign, or strengthening of the quality management system.

Deliverables
• QMS gap assessment against current regulation
• Design or redesign of procedures and governance
• Quality culture program
• Ongoing oversight (retainer model)

6. Inspection Observation Response

Support drafting formal responses to health authority observations and executing the associated remediation.

Deliverables
• Root cause analysis of each observation
• Drafting of the formal response to the authority
• CAPA plan with effectiveness follow-up

7. Data Integrity

Audit and design of data governance, aligned with ALCOA+ criteria and growing local authority expectations.

Deliverables
• Data integrity audit of critical systems
• Design of data governance and controls
• Remediation plan for identified gaps

8. Pharmacovigilance – Diagnostic and System Design

Evaluation and design of the pharmacovigilance system as a scoped project, not an ongoing operation.

Deliverables
• Diagnostic audit of the pharmacovigilance system
• Design of the pharmacovigilance quality system
• Pharmacovigilance mock inspection

9. “On-Call” Model

Rapid-response GMP retainer consulting for clients who want access to expert advice without opening a formal project.

Deliverables
• On-demand access to expert consultation
• Defined response time per service agreement
• Monthly/quarterly subscription model