✦ AI-native GMP compliance

GMP Compliance Intelligence.
Always Available.

The AI-native GMP compliance platform built for pharmaceutical manufacturers in the Arab world. Replace expensive consultants and outdated QMS software with 24/7 intelligent compliance guidance — in Arabic and English.

🔒 Data hosted in Germany · 🌍 WHO · EU GMP · ICH Q9 · 🇸🇦 🇦🇪 🇯🇴 🇪🇬 Arab world · 🇬🇧 QUALIVA LTD — UK
Qualiva Platform
🔍Issue
Troubleshooter
⚠️Deviation
& CAPA
Audit
Readiness
📊Batch
Records
🌡️Stability
Studies
🛡️Risk
Management
Ask Qualiva AI ✦ All modules

Pharmaceutical QA in the Arab world has a knowledge problem.

The tools that factories actually need — at the price they can actually pay — have never existed. Until now.

💸

Consultants are too expensive

GMP consultants cost $5,000–$15,000/month — and they're not available at 3am during a production crisis.

📋

Legacy QMS is built for the West

Legacy QMS platforms cost $10,000–$20,000/month per module, require 6-month implementations, and were never designed for Arabic operations.

🧠

Knowledge leaves with people

Junior QA staff don't know if the SOP they're writing is correct. Senior staff are too stretched to check everything. Knowledge walks out the door when people leave.

Qualiva is your factory's permanent GMP intelligence layer.

Three things that make Qualiva unlike anything you've seen before.

AI-native

Every module is intelligently assisted. Qualiva doesn't just store data — it analyses deviations, suggests root causes, drafts documents, flags risks, and prepares your audit responses. AI is not a feature. It is the platform.

🌍

Arabic-first

Fully bilingual — Arabic and English throughout. RTL layout, Arabic UI, Arabic document generation, Arabic voice input. Built for the region, not translated for it.

🏭

Pharma insiders

Built by a team with deep pharmaceutical manufacturing expertise across the MENA region. Every feature exists because a real factory needed it — not because a software developer imagined it.

17 modules. One platform. The complete GMP compliance lifecycle.

From issue troubleshooting to EU GMP certification — every workflow your factory needs.

🔍

Issue Troubleshooter

AI-powered root cause analysis for any GMP issue

محلل الأسباب الجذرية
⚠️

Deviation & CAPA

Log, investigate, and close deviations with AI guidance

الانحرافات والإجراءات التصحيحية
🔄

Change Control

GMP-compliant change management with impact assessment

إدارة التغييرات
📄

SOP Intelligence

Upload, classify, and query your SOPs with AI

مركز ذكاء الإجراءات

Audit Readiness

Continuous GMP readiness score and gap detection

محرك الجاهزية للتدقيق
📊

Batch Records

Digital batch manufacturing records with AI release

سجلات الدفعات الرقمية
🤝

Supplier Quality

Supplier qualification, audits, and risk scoring

جودة الموردين
🌡️

Stability Studies

ICH Q1 stability with climate zone IVb support

دراسات الثبات
🗂️

Document Library

Controlled document management with expiry tracking

مكتبة الوثائق
📝

GMP Templates

AI-generated GMP documents and logbooks

قوالب GMP الذكية
🎓

Training Management

Staff training records, matrix, and competency tracking

إدارة التدريب
📢

Complaints & Recalls

End-to-end complaint handling and recall management

الشكاوى والاسترجاع
🛡️

Risk Management

FMEA and Risk Register following ICH Q9

إدارة المخاطر ICH Q9
🧪

Material Management

Raw materials, packaging, and QC release workflow

إدارة المواد
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QC Laboratory

Instruments, test methods, and OOS result management

مختبر مراقبة الجودة
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Self-Inspection

Structured internal GMP audits with AI reporting

برنامج التفتيش الذاتي
🇪🇺

EU GMP Pathway

Full Annex 11 compliance roadmap for EU certification

مسار EU GMP / Annex 11
See all features →
⚡ Live on this page

Ask Qualiva anything. Right now.

The Ask Qualiva AI assistant is built into every page of this website. Click the chat button in the bottom corner and ask about our modules, pricing, regulatory coverage, or anything GMP-related. No login required.

Try it — ask a question →
Does Qualiva support WHO GMP and EU GMP?
Yes — Qualiva covers WHO GMP (TRS 986/1044), EU GMP Parts I & II, Annex 1 and Annex 11, ICH Q9 (Risk Management), ICH Q10 (Pharmaceutical Quality System), and the Arab GMP Code. The EU GMP Pathway tier provides a dedicated Annex 11 compliance roadmap and vendor validation package.
كم يكلّف الاشتراك؟
تبدأ الأسعار من $3,500 شهرياً للخطة Pro، و$7,500 للخطة Pro Intelligence، و$12,000 لمسار EU GMP. جميع الخطط تشمل 5 مقاعد ومساعد الذكاء الاصطناعي.

Transparent pricing. No hidden fees. No implementation consultant.

Three tiers designed to match where your factory is today.

Pro
$3,500 /month
Core GMP compliance for manufacturing facilities
  • All core compliance modules
  • 5 seats included
  • 1,000 AI queries/month
  • Arabic + English bilingual
  • Ask Qualiva AI assistant
Start with Pro →
EU GMP Pathway
$12,000 /month
Full EU regulatory certification pathway
  • Everything in Pro Intelligence
  • Annex 11 compliance roadmap
  • Vendor Validation Package
  • 5,000 AI queries/month
  • Priority support
Contact us →

All plans include 5 seats · Extra seats $300/user/month · Annual billing saves 17% · 30-day paid pilot with full refund guarantee

See full pricing →

Built for the standards that matter.

Qualiva covers every major GMP framework relevant to pharmaceutical manufacturers in the Arab world.

WHO GMP
EU GMP Parts I & II
Annex 11
Annex 1
ICH Q9
ICH Q10
Arab GMP Code
Climate Zone IVb
🇩🇪

Data in Germany

Hosted at Hetzner Cloud, Nuremberg — EU jurisdiction. Never used for AI training.

🇬🇧

UK Registered

QUALIVA LTD — Companies House, United Kingdom. International-standard software infrastructure.

🏭

Pharma insider team

Built by a team with deep pharmaceutical manufacturing expertise across the MENA region.

Your factory's GMP intelligence layer is ready.

Request a demo today. One month paid pilot. Full refund if no value demonstrated in 30 days.

Request a Demo
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