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Data shown across the platform is illustrative and unverified — not for vendor qualification or regulatory use.

Quality, Safety & Regulatory

Engineering & CQV

Cleanroom, commissioning & validation

2

firms listed

Facility design, cleanroom, commissioning, qualification and validation partners — ranked on CQV and inspection readiness.

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Firm names are real companies; disciplines, compliance, project metrics and satisfaction figures are synthetic demonstration data. Scores/ranking are deterministic, rules-based — not AI. Not a determination of fitness; do not use for procurement decisions.

MarketplacesEngineering & Validation

2 firms

Sort

CQV readiness Engineering breadth Cleanroom expertise Regulatory alignment Delivery scale Documentation maturity Name (A–Z)

Modalities served

API2 Biologics2 mAbs2 Sterile injectables2 Vaccines2 Cell therapy1 Small molecules1

Capabilities

Turnkey EPCM Cleanroom design Commissioning CQV program mgmt CSV Verified

Regulatory agencies

FDA EMA MHRA PMDA NMPA WHO

Annual revenue

$50M – $250M2 $250M – $1B6 $1B – $5B3 $5B+2

Team size

Any team size 1,000+ staff 2,500+ staff 5,000+ staff

Validation deliverables

Any deliverables 2,000+ deliverables 3,000+ deliverables 5,000+ deliverables

Facilities commissioned

Any facilities 100+ commissioned 140+ commissioned 180+ commissioned

Projects completed

Any projects 250+ projects 300+ projects 400+ projects

Countries served

Any reach 15+ countries 20+ countries 30+ countries

Areas served

Europe12 United States12 Global10 Switzerland7 Ireland6 Singapore6 United Kingdom5 India4 France3 Germany3

Country

Croatia Denmark France Germany India Ireland Italy Sweden USA United Arab Emirates

Showing 2 of 2Clear filters ADCs API mAbs Cell therapy Ireland

Cork, Ireland · Ireland

100CQV

EngineeringEPCMProcess engineeringUtility engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 100REG 842 projects

Turnkey EPCMFull-scope CQV

Dublin, Ireland · Ireland

89CQV

EngineeringArchitectureEPCMProcess engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 96REG 672 projects

Turnkey EPCMFull-scope CQV