QMS maturity and gap assessment
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
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Gaps triaged
QMS Action Plan
StatusGaps triaged
Our craft
Built around real quality systems practice.
Service Detail
Strengthen PV quality systems before inspection pressure.
PharmaRevix develops SOPs, performs GAP analysis, supports internal audits, and prepares teams for mock inspection across pharmacovigilance and regulatory operations.
Your PV or regulatory SOPs are outdated
You are preparing for inspection or audit
You need a structured gap assessment
You need CAPA and remediation support
Deliverables
Practical outputs your team can use immediately.
SOP map and controlled document plan
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Audit or mock-inspection agenda
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
CAPA tracker with owners and due dates
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Training and implementation evidence
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Inspection readiness dashboard
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Workflow
A clear sequence from assessment to handoff.
01
Assess
Assess current SOPs, records, and operating model
02
Plan
Benchmark against applicable authority expectations
03
Execute
Prioritize gaps by compliance risk and operational impact
04
Maintain
Support remediation, training, and inspection readiness
Proof Package
Every engagement leaves an evidence trail.
The work is designed for real review: authority questions, partner due diligence, quality audits, and internal leadership updates.
SOPsAudit readySenior-led
PV and regulatory SOP development
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
GAP analysis against EMA, USFDA, Health Canada, and regional expectations
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Internal audit and mock-inspection support
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
CAPA and remediation action tracking
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Related Services
Connect this work with adjacent regulatory and safety needs.
PV System Setup & Maintenance
PharmaRevix builds and maintains pharmacovigilance systems, including PSMF authoring, safety database setup, SDEAs, data migration, and ongoing stewardship.
Explore serviceRegulatory Intelligence
Regulatory expectations move quickly. PharmaRevix monitors authority updates, guidance changes, market signals, and competitor movement so your team can act before issues become urgent.
Explore serviceQPPV & Local Representative Services
PharmaRevix provides EU and UK QPPV, Deputy QPPV, Local Safety Officer, Contact Person, and local representative support where required by national legislation.
Explore serviceFAQ
Common questions about QMS & GAP Analysis.
Short answers for teams deciding whether this is the right next step.
Ask us anythingQMS and GAP analysis identifies compliance gaps, strengthens SOPs, supports internal audits, and prepares teams for mock inspection across PV and regulatory operations.
Yes. PharmaRevix can scope this as a standalone workstream or connect it with adjacent regulatory affairs, pharmacovigilance, QMS, and submission activities.
Yes. PharmaRevix can scope this as a standalone workstream or connect it with adjacent regulatory affairs, pharmacovigilance, QMS, and submission activities.
Free 30-minute consultation
Need qms & gap analysis support?
Talk with PharmaRevix about scope, timelines, and the cleanest next step for your market or safety obligation.