Experts in Commissioning, Qualification & Validation
We deliver end-to-end Commissioning, Qualification, and Validation solutions that empower biotech companies to launch compliant facilities, accelerate readiness, and uphold the highest global standards.
From complex validation projects to full-scale technology transfers, we are your trusted partner in ensuring operational excellence.
From complex validation projects to full-scale technology transfers, we are your trusted partner in ensuring operational excellence.
Zyme Biotech
Welcome to Zyme Biotech, a global leader in CQV and biotech project delivery.We empower pharmaceutical and biotech companies to accelerate facility readiness, ensure compliance, and maintain the highest quality standards across every stage of manufacturing.
Trusted by leading global innovators, we provide strategic insight and hands-on execution that drive real-world results.
At Zyme Biotech, we don’t just consult—we partner with you to build, validate, and sustain excellence.
At Zyme Biotech, we don’t just consult—we partner with you to build, validate, and sustain excellence.
CQV Innovation Leaders
Driving biotech progress through advanced validation engineering.
Optimized CQV frameworks across global GMP standards
Integration of digital validation and data integrity tools
Proven success in first-time inspection readiness
Scale-Up & Facility Readiness
Expertise in taking biotech operations from lab to commercial scale.
Process validation and performance qualification
Start-up and tech transfer management
GMP-compliant facility commissioning
Operational Excellence & Compliance
Sustaining long-term performance through continuous improvement.
Audit preparation and QMS optimization
Risk-based validation and lifecycle management
ongoing compliance and lifecycle validation management
From Concept to Qualified Facility
Partnering to turn scientific vision into compliant operations.
Design qualification and project execution
Global regulatory alignment (EU, US, GCC)
Training and knowledge transfer for CQV teams
Our Process
Every project starts with understanding your science, systems, and standards and ends with a fully qualified, inspection-ready facility.
Discover & Define
We assess existing systems and identify compliance gaps, risk areas, and process opportunities.
Operations and documentation review
Risk and criticality assessment
Action plan aligned with GMP and regulatory expectations
Strategise & Plan
We design a validation roadmap that aligns with your business goals and regulatory standards.
Detailed CQV strategy and protocol design
Integration of digital validation systems
Defined KPIs for success tracking
Implement & Optimize
Hands-on execution to ensure every system performs as intended.
Equipment commissioning and qualification
Cleaning, process, and computer validation
Onsite support and team training
Evaluate & Sustain
We measure, refine, and sustain operational performance.
Performance monitoring and trending
Ongoing compliance verification
Continuous improvement programs
Shaping the future of biotechnology
From initial assessment and CQV strategy development to execution and handover, we deliver tailored solutions that ensure precision, compliance, and performance at every stage of your facility’s lifecycle.
Our commitment to technical excellence and innovation drives us to deliver results that meet global GMP standards and exceed our partners’ expectations.
Our commitment to technical excellence and innovation drives us to deliver results that meet global GMP standards and exceed our partners’ expectations.
Digital Validation , The Next Step in CQV Evolution
Manual documentation, fragmented data, and lengthy approval cycles often create bottlenecks that delay project timelines and introduce compliance risks. Digital validation is emerging as the modern answer to these challenges enabling biotech and pharmaceutical organisations to manage the Commissioning, Qualification & Validation (CQV) lifecycle with precision, transparency, and control.
Modular Construction Transforming GMP Facilities in the Middle East and Beyond
The pharmaceutical and biotechnology industries are undergoing a transformative shift in facility construction, with modular building solutions emerging as a game-changing approach, particularly for Good Manufacturing Practice (GMP) projects.
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Zyme Biotech and ValGenesis Partner
Zyme Biotech, a leading provider of strategic solutions for the biopharmaceutical and life sciences industries, proudly announces a groundbreaking partnership with ValGenesis.
