Expert GMP document review, delivered to your portal.
Upload your SOPs, validation protocols, and batch records. CQMP compliance specialists review each document against FDA, EU GMP, and ISO standards — and return a detailed findings report with gap analysis, risk ratings, and corrective actions.
Why it matters
What you get with every review
More than a compliance check — a structured, expert-led review that prepares your documentation for inspection.
Expert compliance review
Every document is reviewed by a CQMP compliance specialist against FDA, EU GMP, and ISO 13485 standards — not a checklist tool.
Gap identification & risk rating
Each finding is rated by risk level — critical, major, or minor — so your team knows exactly where to focus remediation efforts.
Actionable findings report
You receive a structured report per document with specific corrective action recommendations, not vague observations.
Secure portal delivery
Documents are uploaded and returned through your private CQMP portal. Nothing is shared outside your account.
Fast, predictable turnaround
Packages come with a defined turnaround window so you can plan your compliance timeline with confidence.
Audit-ready documentation
Reviewed documents and findings reports are stored in your portal, ready to present during an FDA or EU GMP inspection.
Simple process
From upload to findings in four steps
Register for the portal
Create your CQMP client account at no cost. Takes under two minutes.
Choose your package
Select the review tier that matches your document volume — Starter, Professional, or Enterprise.
Upload your documents
Upload SOPs, protocols, batch records, or any GMP documentation directly through your secure portal.
CQMP reviews & returns findings
Our compliance specialists review each document and upload a detailed findings report back to your portal.
What we review
Any GMP document your team produces
Our compliance specialists are experienced across the full range of GMP documentation — from foundational SOPs to complex validation packages. If it needs to survive an inspection, we can review it.
Start your first reviewStandards coverage
Reviewed against the regulations that matter
FDA 21 CFR Part 11
Electronic records & signatures
FDA 21 CFR Part 820
Quality system regulation
EU GMP Annex 11
Computerised systems
ISO 13485
Medical device quality systems
ICH Q10
Pharmaceutical quality system
GAMP 5
Risk-based validation
Review packages
Choose the package that fits your volume
Register for your portal account, select a package, and upload your documents. Pricing is confirmed upon registration.
Starter
- Up to 5 GMP documents reviewed
- Compliance findings report per document
- Gap analysis vs. applicable regulations
- Risk rating per finding (critical / major / minor)
- Recommended corrective actions
- Secure portal upload & delivery
Professional
- Up to 10 GMP documents reviewed
- Compliance findings report per document
- Gap analysis vs. applicable regulations
- Risk rating per finding (critical / major / minor)
- Recommended corrective actions
- Secure portal upload & delivery
- Priority review queue
Enterprise
- Up to 25 GMP documents reviewed
- Compliance findings report per document
- Gap analysis vs. applicable regulations
- Risk rating per finding (critical / major / minor)
- Recommended corrective actions
- Secure portal upload & delivery
- Priority review queue
- Dedicated compliance consultant
- Executive summary report
Pricing is confirmed upon registration. All packages include secure document handling and a dedicated CQMP compliance reviewer. Need a custom volume? Contact us.
Ready to get started?
Your next inspection starts with your documents.
Register for your CQMP portal account, choose a review package, and upload your documents. Our compliance specialists handle the rest.