Accelerate Your Path to the European Market
Discover how ready your organization is to bring pharmaceutical or biotech products to Europe — and what's missing to get there faster, smarter, and fully compliant.
Answer a few quick questions to get your personalized EU Market Readiness Score, estimated time-to-approval, and action plan.
Important: This assessment provides a non-binding, informational readiness score only. It does not constitute regulatory advice or a marketing authorisation decision under applicable EU regulations.
Why Use Our EU Readiness Assessment?
Get clarity on your European market entry timeline and identify potential roadblocks before they become costly delays.
Accurate Timeline Estimates
Based on your current regulatory readiness, get realistic timelines for EU market authorization that you can plan around.
Identify Critical Gaps
Spot missing elements in your QMS, GMP certification, CTD/eCTD dossier, and PV system before they delay your launch.
- QMS & GMP readiness
- CTD/eCTD dossier status
- MAH & pharmacovigilance
Expert Guidance
Connect with QbD's regulatory experts who have guided pharmaceutical and biotech companies to European success.
Typical EU Approval Timelines
See how your preparation level affects your time to market.
12–18 months
- • Certified QMS (EU GMP / ISO)
- • CTD/eCTD submission-ready
- • GMP certification valid
- • MAH and PV in place
18–24 months
- • QMS implemented (not certified)
- • CTD/eCTD in progress
- • GMP inspection planned
- • MAH under discussion
24–36 months
- • No QMS in place
- • No GMP certification
- • CTD/eCTD not started
- • No MAH or PV system
Ready to Discover Your EU Readiness Level?
Take our 2-minute assessment and get your personalized timeline with expert recommendations.