Quality & Compliance
Inspection-Ready.
Every Day.
GxP auditing, QMS design & SOP architecture, mock FDA/EMA inspections and CAPA management — building a compliance culture that holds up under real-world scrutiny, not just on inspection day.
ISO 90012015 Certified
Overview
A Compliance Culture, Not a Project.
Inspection readiness can't be sprinted to. Teams that scramble in the four weeks before an FDA BIMO inspection are the teams that get 483s. The companies that pass cleanly built the muscle months earlier — operating to inspection-grade standards as a daily discipline, not a campaign.
Vigilare's quality practice builds that muscle. GxP audits across GCP, GLP, GMP, GVP and GDP; QMS design from the SOP architecture up; mock inspections that match real FDA / EMA format; CAPA frameworks that close findings instead of accumulating them.
- GxP auditing across GCP, GLP, GMP, GVP and GDP
- QMS design from the SOP and quality manual upward
- Mock inspections matching real FDA BIMO and EMA inspection format
- CAPA frameworks designed to close findings — not paper over them
Offerings
Every Quality Function. Built In, Not Bolted On.
Six integrated quality and compliance capabilities — engage as project audits or as a long-term quality partnership.
GxP Auditing
GCP (site, sponsor, CRO, vendor), GLP (non-clinical), GMP (API + drug product), GVP (PV systems), GDP (distribution). Routine and for-cause.
QMS Design & SOPs
Quality manual authoring, SOP architecture, work-instruction trees, document control, change management, training matrices.
Mock FDA / EMA Inspections
Full-format mock inspections: opening meeting, walk-throughs, document and case sampling, signal-management review, exit briefing, graded findings.
CAPA Management
Root-cause analysis (5-Why, fishbone, Pareto), corrective and preventive action design, effectiveness checks, trending, executive QC dashboards.
Inspection Readiness Programs
Ongoing readiness assessments, document storyboarding, interview rehearsals, inspection-room set-up, real-time war-room support during inspections.
GxP Training & Onboarding
Role-based GxP training, SOP onboarding, computer-system validation training, role-competency matrices and effectiveness tracking.
ISO 90012015 Certified
5 GxPsGCP · GLP · GMP · GVP · GDP
30+Markets · Multi-Region Audits
10+Years Quality Mastery
Our Process
From Gap Assessment to Inspection Day
A five-stage quality framework designed to make inspection readiness a daily discipline, not a quarterly fire drill.
01
Assess
Baseline QMS audit, SOP gap analysis, document-control review, training matrix audit.
02
Design
Quality manual, SOP architecture, doc-control workflow, training and competency framework.
03
Implement
Roll out SOPs, document control, change management, CAPA, deviation processes.
04
Train
Role-based GxP training, SOP onboarding, refresher cycles, competency verification.
05
Audit
Continuous internal audits, mock inspections, executive QC reporting, CAPA closure tracking.
Why Vigilare
Built for Real Inspections. Not Audit Theatre.
Four reasons biopharma and MedTech sponsors choose Vigilare for quality and compliance.
ISO 9001:2015 Certified — Externally Audited
Our own quality system passes annual external surveillance audits. We don't recommend you do anything we don't already do.
Ex-Agency Auditors on the Team
Our senior auditors include former FDA, EMA and MHRA inspectors — they audit by the rule book they used to enforce.
Five-GxP Coverage In-House
GCP, GLP, GMP, GVP and GDP all delivered by named senior auditors in our team — not a network of freelancers.
CAPA That Actually Closes
We design CAPA frameworks to close findings — not to accumulate open items. Effectiveness checks built in from day one.
FAQs
Quality & Compliance, Answered.
01
We have a pre-approval inspection coming up. Can you help us prepare?
Yes — pre-approval inspection (PAI) prep is one of our most common engagements. We run a 5-day diagnostic audit, identify the highest-risk findings, build storyboards for each, rehearse interviews with key personnel, and stand up a war-room for the actual inspection. Most sponsors engage us 60–120 days out.
02
Which GxPs do you cover?
GCP (sites, sponsors, CROs, vendors), GLP (non-clinical labs), GMP (API and finished drug product manufacturing), GVP (pharmacovigilance systems), and GDP (distribution and logistics). All under one ISO 9001:2015 certified quality system.
03
Can you build a QMS from scratch for a new biotech?
Yes. We've designed QMS systems from the quality manual up for first-time-IND biotechs, including SOP architecture, document control, change management, deviation processes, training matrices, supplier qualification and audit programmes. Typical scope: 90–120 days.
04
Do you have ex-FDA / ex-EMA inspectors on your team?
Yes — our senior auditor pool includes former FDA, EMA, MHRA and CDSCO inspectors. Their inspection lens is the one your auditors will use — and they know what gets escalated, what gets a 483, and what gets a warning letter.
05
Can you support us during a real FDA inspection?
Yes. We provide on-site war-room support during real inspections: real-time response coordination, document retrieval, story consistency checks, post-inspection 483 response drafting, and warning-letter remediation if needed.
Related Services
Pair Quality with the Full Lifecycle
Bundle quality with safety, regulatory, clinical and market access — one team, one quality system.
Ready to make inspection readiness a daily discipline?
Speak to a senior quality lead — not a sales rep. We'll diagnose your current QMS, identify the highest-risk gaps and propose a path in one focused call.