Compliance, Gap Analysis & Remediation
Close the Gaps
Before the Auditor Does.
An inspection finding doesn't happen overnight; it's usually the result of small compliance gaps that went unaddressed. We help pharma and biotech companies identify those gaps early and close them before they become regulatory findings.
RealInspection Criteria
Overview
An Audit-Readiness Approach
We assess your current quality systems, documentation, and processes against applicable GxP standards, then build a practical roadmap to close identified gaps.
Our gap analysis methodology is built around real inspection criteria used by health authorities — giving you a realistic view of your compliance standing, not just a checklist exercise.
- Assessment against GVP, GCP and GMP requirements
- Identification of concrete compliance shortfalls
- CAPA planning with tracking to closure
- Mock audits and inspection documentation review
What We Deliver
Gap Assessment & CAPA
A structured path from assessment to closure, built on real inspection criteria.
GxP Compliance Audits
Assessment against GVP, GCP, and GMP requirements.
Regulatory Gap Assessment
Identification of compliance shortfalls across systems.
CAPA Development
Corrective and Preventive Action planning and tracking.
Inspection Readiness Support
Mock audits and documentation review.
Remediation Planning
Structured timelines for closing compliance gaps.
5Major Health Authorities
5Global Regions
ISO9001:2015 Certified
10+Years of Expertise
Our Approach
From Assessment to Closure
A remediation cycle that turns findings into a defensible compliance position.
01
Assess
Audit current systems, documentation and processes against GxP.
02
Identify
Pinpoint concrete compliance shortfalls and root causes.
03
Plan
Build a CAPA plan with owners and realistic timelines.
04
Remediate
Close gaps and strengthen documentation and controls.
05
Verify
Mock inspection to confirm readiness before the real audit.
Why Vigilare
Realistic, Not a Checklist
Compliance guidance grounded in how inspectors actually work.
Built on Inspection Criteria
Methodology mirrors the criteria health authorities use in real inspections.
Catch Gaps Early
Find and close small gaps before they become inspection findings.
CAPA That Closes
Corrective actions tracked to genuine closure, not just logged.
Inspection Confidence
Mock audits so your teams are never caught unprepared.
FAQs
Answered. Clearly.
01
What is gap analysis in pharma?
Gap analysis in pharma involves comparing a company's current processes and documentation against regulatory requirements to identify compliance shortfalls before they lead to inspection findings.
02
How do I prepare for regulatory audits?
Preparing for regulatory audits involves conducting internal gap assessments, reviewing documentation and quality systems, running mock inspections, and addressing identified issues through a CAPA plan.
Related Services
Explore the Full Practice
Prepare for your next audit with confidence.
Request a gap analysis and get a realistic view of your compliance standing — plus a practical plan to close it.