Novatek International

Novatek International delivers process-driven LIMS, quality execution, and contamination control software for pharmaceutical, biotech, and healthcare industries. Founded in 1996 by Aram Montazami, the company provides software solutions that help manufacturers digitalize operations while complying with global GMP regulations.

Headquartered in Montreal, Canada with a key office in Paris and a network of international partners, Novatek serves customers across 4 continents including North America, Europe, and Asia. The company's Contamination Control Suite (Environmental Monitoring, Cleaning Validation, Utilities Monitoring) has over 20 years of industry use as an "off the shelf" solution that evolved through continuous improvement based on user specifications and regulatory requirements.

Partnership with MasterControl integrates Novatek's specialised environmental monitoring and cleaning validation solutions with MasterControl's QMS platform. The company also partners with CCRM, a leader in regenerative medicine and cell/gene therapies commercialization.

Novatek International serves pharmaceutical, biotech, and healthcare manufacturers with GMP-compliant software solutions. The company's Environmental Monitoring Software has over 20 years of industry use, evolving through continuous improvement based on pharmaceutical user specifications and regulatory requirements.

Products designed specifically for GMP-regulated environments with 21 CFR Part 11 and EU Annex 11 compliance. Cleaning validation software designed per PDA Technical Reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67, and EU Annex 15 standards. Partnership with MasterControl extends reach to MasterControl's pharmaceutical customer base. Also partners with CCRM for cell and gene therapy applications.

Private company with no disclosed external funding (bootstrapped). Annual revenue reported as $35M as of August 2025, generating approximately $385K revenue per employee. The company has maintained profitability and growth without venture capital investment since founding in 1996.

No M&A activity or acquisition reported. Company maintains private ownership structure with founder Aram Montazami.

Novatek Contamination Control Suite includes three integrated modules: Environmental Monitoring Software (20+ years of use), Nova-Cleaning Validation (Nova-CVM for automated cleaning validation and risk management), and Utilities Monitoring Software. Additional products include Nova-LIMS for laboratory information management and Quality Management System modules.

Nova-Cleaning Validation automates worst-case determination and MAC (Maximum Allowable Carryover) calculations, executing hundreds of calculations in seconds instead of hours. The platform includes computerized risk-based worst-case evaluation, automated sampling protocol generation, and process-dedicated change evaluation. All solutions comply with 21 CFR Part 11 and EU Annex 11, designed as "off the shelf" solutions with continuous improvement based on regulatory requirements.

Strategic partnership with MasterControl integrating Novatek's specialized environmental monitoring and cleaning validation solutions with MasterControl's QMS platform. Partnership with CCRM (Centre for Commercialization of Regenerative Medicine) for cell and gene therapy applications.

Software integrates with existing pharmaceutical manufacturing systems. Network of international implementation partners supports global deployments. Technology built for regulated pharmaceutical environments with focus on data integrity and compliance.

Global support through headquarters in Montreal, Paris office, and network of international partners across 4 continents. Implementation services for software deployment and configuration. Training programs for GMP compliance and system administration.

Products designed as "off the shelf" solutions requiring minimal customization. 20+ years of customer feedback incorporated into continuous product improvement. Specific support hours, SLA terms, and certification programs not publicly disclosed.

29-year track record since founding in 1996. Environmental Monitoring Software described as "industry-proven standard" with 20+ years of pharmaceutical industry use. Solutions evolved through continuous improvement process based on user specifications and regulatory requirements.

Listed on G2 with 1 review. Partnership with MasterControl, a major QMS vendor. Compliance frameworks named: 21 CFR Part 11, EU Annex 11, PDA Technical Reports 29 and 49, ISPE MaPP, and EU Annex 15. Undisclosed: ISO certifications, analyst awards.

Website highlights GMP LIMS and contamination control solutions. Demo availability by request. Product documentation covers cleaning validation, environmental monitoring, and LIMS capabilities.

Limited social media presence and review platform coverage (1 G2 review). Market positioning as specialized contamination control and validation software vendor for pharmaceutical manufacturing. Website emphasizes 20+ years of industry experience and regulatory compliance expertise.