Preparing your pharmaceutical
organization for
inspections with structured
remediation
Schedule a consultation
Inspection Readiness service.
Assessment
Initial gap assessment, risk review, and readiness scoring to identify vulnerabilities before inspectors do.
Preparation
Document organization, evidence mapping, mock inspections, and staff training to build inspection confidence.
Execution
On-site coaching, SME alignment, document control flow, and real-time support during inspection days.
Response & Improvement
CAPA strategy, observation/483 responses, regulatory alignment, and system strengthening for future inspections.
Details about our End-to-End
Inspection Readiness Support.
Pre-Inspection Assessment & Audit (Gap & Risk Review)
Full audit-style review of your QMS, operations, documentation, and data integrity practices to identify gaps before inspectors do.
Includes document organization, evidence mapping, and verification of GMP/GCP/GDP compliance.
Mock Inspections (EU GMP, GDP, FDA, PIC/S)
Realistic mock audits led by senior QPs/QA experts to surface vulnerabilities, test your teams under inspection pressure, and simulate real regulatory scenarios.
Documentation, Data Integrity & Audit Trail Review
Verification that batch records, QC data, deviations, CAPAs, change controls, audit trails, and traceability meet inspector expectations.
Clear mapping of evidence so inspectors can easily follow your decision-making processes.
Staff Training for Inspection Behavior
Targeted coaching for operators, SMEs, QA, QPs, and leadership on how to respond clearly, confidently, and accurately to inspector questions.
Training includes communication protocols and handling high-pressure interactions.
Facility & Process Walkthroughs
On-site or virtual walkthroughs of manufacturing, QC, distribution, and support areas to ensure operational compliance before inspectors arrive.
Observation / Deficiency Response Support
Drafting, reviewing, and strengthening responses to Form 483s, FDA observations, EU inspection reports, or PIC/S findings.
Includes CAPA strategy, justification writing, and evidence preparation.
Inspection-Day Coaching & Support
Guidance for SMEs, QPs, RP, and leadership during the inspection: document control, escort roles, communication flow, and behavior in the inspection room.
Observation Management & Response Templates
Pre-approved templates and standardized response structures that accelerate reaction time and ensure regulatory accuracy when findings occur.
Inspection readiness doesn’t happen,
YOU build it.
Being prepared means more than passing an audit. It means protecting approvals, strengthening your quality system, and giving your teams the confidence to face any authority.
- Avoid regulatory setbacks
- Protect market access
- Preserve your reputation
- Strengthen quality systems
- Empower your teams
Let’s define your next
compliance step
Share your context below and we will schedule a structured consultation to assess your regulatory and operational priorities.
