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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

31

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

31 firms

Sort

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

Modalities served

Cell therapy13 Vaccines13 Biologics12 Sterile injectables12 Gene therapy11 mAbs8 API6 Viral vectors5 Peptides3 Small molecules2 ADCs1 Other1

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 11 of 31Clear filters India Singapore Germany

CAI

Commissioning Agents Inc (CAI)

Indianapolis, USA · United States

100CQV

CQVValidationCSVProcess engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 65REG 1003 projects

CommissioningFull-scope CQV

Cork, Ireland · Ireland

100CQV

EngineeringEPCMProcess engineeringUtility engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 100REG 842 projects

Turnkey EPCMFull-scope CQV

IPS – Integrated Project Services

Blue Bell, USA · United States

100CQV

EngineeringArchitectureEPCMProcess engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 100REG 923 projects

Turnkey EPCMFull-scope CQV

Dallas, USA · United States

100CQV

EngineeringArchitectureEPCMProcess engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 99REG 1003 projects

Turnkey EPCMFull-scope CQV

E

Stuttgart, Germany · Europe

89CQV

EngineeringCleanroom engineeringEPCMProcess engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 96REG 672 projects

Turnkey EPCMFull-scope CQV

N

Virum, Denmark · Europe

89CQV

EngineeringCleanroom engineeringProcess engineeringUtility engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 94REG 672 projects

CommissioningFull-scope CQV

Dublin, Ireland · Ireland

89CQV

EngineeringArchitectureEPCMProcess engineering

FDACQVFDA cGMPEU GMP Annex 1ICH guidelines

ENG 96REG 672 projects

Turnkey EPCMFull-scope CQV

Europe

48CQV

FDA

ENG 0REG 160 projects

EngineeringDeveloping CQV

Erlangen, Germany · Europe

33CQV

EngineeringAutomation engineering

FDA

ENG 6REG 160 projects

EngineeringCQV specialist

Italy · Europe

21CQV

FDA

ENG 0REG 80 projects

EngineeringCQV specialist

HVAX Technologies

India · Asia

15CQV

EngineeringCleanroom engineeringValidation

FDA

ENG 23REG 320 projects

Turnkey EPCMCQV specialist