GMP Expertise · AI Tools · Real Results

Big companies have dedicated teams. You have one person doing it all.

QualyAgent gives small pharma, biotech and food companies direct access to GMP expertise and AI tools.

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Annex 1 · ICH Q7 · ICH Q10

AI Document Review

CAPA · Change Control · Deviation · Risk Assessment

Consistency and compliance check
Root cause analysis — complete and traceable
Corrective actions — specific, measurable, time-bound
Effectiveness check — defined and documented
Format aligned with authority requirements
Expert review delivered within 48 hours

How QualyAgent works

Three steps to inspection-ready documents

1

Upload or paste your document

Submit your deviation report, CAPA, change control request or SOP. No special format required. We recommend replacing sensitive identifiers with generic placeholders before uploading.

2

Get an expert AI review

QualyAgent analyzes your document against GMP requirements and gives you structured feedback, gap identification and a suggested revision. In minutes, not days.

3

Review with a human expert

On Professional and Team plans, a GMP specialist reviews the AI output and adds practical recommendations based on real inspection experience. You get a final document ready for your QMS.

Pricing

Simple, transparent pricing

No setup fees. No long-term contracts. Cancel anytime. Monthly billing.

On-Demand Review

€45

per document

Single expert review with no subscription or commitment. Pay only when you need it.

  • 1 expert human review — any GMP document type
  • CAPA, deviation, SOP, change control, risk assessment
  • Written feedback within 48 hours
  • No subscription, no commitment

Perfect for teams that need occasional expert support without a monthly plan.

Get Started

Professional

€299

per month

For QA managers and small quality teams who need expert support on a regular basis.

  • Unlimited access to all AI quality tools (CAPA, deviation reports, change control, SOP gap analysis)
  • 5 expert human reviews per month with written feedback within 48 hours
  • GMP template library (deviation log, CAPA plan, change control form, risk assessment matrix, SOP checklist)
  • Email support — response within 72 business hours

Best for companies with 10 to 50 employees preparing for audits or managing ongoing quality documentation.

Get Started

Email support covers service and technical questions.
GMP-specific guidance is included in your monthly expert reviews.

Most Complete

Team

€499

per month

For quality teams that need broader coverage, multiple users and deeper expert involvement.

  • Everything in Professional
  • Up to 5 user accounts
  • 30 expert human reviews per month
  • Monthly 30-minute call with a GMP specialist
  • Data Processing Agreement (DPA) included — GDPR & Swiss nLPD compliant
  • Priority email support — response within 24 business hours

Best for companies with 50 to 100 employees with an active QMS and regular audit cycles.

Get Started

Email support covers service and technical questions.
GMP-specific guidance is included in your monthly expert reviews.

Not sure which plan is right for you?

Book a free 20-minute call and we will help you decide.

Book a Call