INSPECTION READINESS
Inspection Coming?
See the Gaps Before the Inspectors Do
Inspection readiness is more than checking documents. We challenge the study, the systems and the people behind it, Identifying gaps, testing inspection responses and building a clear, defensible quality story before inspectors arrive.
An Inspection Is a Test of the Whole Quality Story
Inspectors don't review documents in isolation. They connect the dots between what was planned, what was done, what was documented, what was reported and how the organization responded when things went wrong.
VedX looks at the complete inspection story. From study conduct and oversight to data integrity, documentation, quality issues and management decisions.
Experience across Major Global Regulatory Authorities
We support inspections and audit readiness for leading regulatory agencies worldwide.
Food and Drug Administration
United States
European Medicines Agency
European Union
Pharmaceuticals and Medical Devices Agency
Japan
Taiwan Food and Drug Administration
Taiwan
Therapeutic Goods Administration
Australia
Health Canada
Canada
Medicines and Healthcare products Regulatory Agency
United Kingdom
What We Cover
Comprehensive support across key areas for a smooth and successful inspection.
Mock Inspections
Simulate the real inspection experience to expose gaps in people, processes, documentation and responses before the actual inspection.
Pre-Inspection Readiness
Assess inspection readiness, prioritize critical gaps and prepare teams, documents and processes for regulatory scrutiny. We arrange series of mock interview and prepare your team to answer better, with storyboards and mind mapping.
Complete Submission Review
Review key submission documents, data and supporting records for consistency, completeness and potential areas of regulatory concern.
Complete Front & Back Room Support
Support inspection strategy, document requests, response coordination and communication across the front and back rooms throughout the inspection.
Customized Inspection Training
Prepare teams with role-specific training, realistic questions and practical techniques for responding confidently and appropriately during inspection.
Remediation & Follow-Up
We support teams in developing clear, evidence-based responses to inspection findings, defining appropriate CAPA and remediation plans, assigning ownership and timelines, and following through to effective closure.
Our Approach
- 01
Regulatory Thinking, Not Checklist Auditing
We look beyond whether documents exist. We assess whether the evidence tells a consistent and defensible story.
- 02
Real-World Inspection Experience
Our approach is shaped by experience across global GCP audits, regulatory inspections and inspection preparation including FDA, EMA, NMPA and other major regulatory environments.
- 03
Study-Level + System-Level Perspective
Inspection risk rarely sits in one department. We connect study execution with QMS, vendor oversight, data, TMF, clinical operations and management oversight.
- 04
We Challenge the Answers
A team that can answer the first question is not necessarily inspection-ready. We use realistic questioning and follow-up challenges to test whether SMEs can explain decisions clearly and consistently.
- 05
Risk-Based, Not Checklist-Based
We focus effort where regulatory and patient/data risk is highest rather than treating every document, process and issue equally.
- 06
Independent Perspective
We provide an independent view of readiness — challenging assumptions and identifying uncomfortable gaps before a regulator does.
Know Where You Stand Before the Inspector Does
Whether an inspection is months away or already on the horizon, we can help you assess readiness, identify the gaps that matter and build a focused path to remediation.