LIFe sciences
Advancing health through expertise and innovation
At Nalys, our Life Sciences expert team support pharmaceutical, biotechnology and medical device companies in delivering progress that improves patients’ lives.
From development to production and from regulatory compliance to QA and validation, our engineers bring hands-on expertise and a passion for excellence at every stage of the value chain.
From design to handover, our project managers and engineers deliver smart, reliable solutions, on time, on budget, and with precision.
By combining scientific insight with a strong focus on quality and compliance, we help our clients accelerate innovation, enhance performance, and ensure the highest standards of patient safety.
Our expertise
What we do
Project Management
- Scope Definition, Quality, Cost forecast, Planning Management, Leadership,
- Reporting, Stakeholder Management, Risk Management
Engineering
- HVAC, clean rooms, Clean & Black Utilities, electricity etc.
- Design & commissioning, install, and maintain pharmaceutical equipment and utilities
- Prepare maintenance plans & spare parts list
- Collaborate with Production, EHS, Maintenance and QA to ensure operational readiness
Process Engineer (Manufacturing / Industrial)
- Upstream, Downstream, filling & packaging
- Mechanical Design & commissioning for process equipment.
- Participate in process validation and continuous improvement initiatives (Lean, Six Sigma)
- Ensure alignment with cGMP, safety, and environmental standards
Automation Engineer
- Support design, implementation/integration, and troubleshooting of automated systems (SCADA, PLC, DCS)
- Develop and maintain automation documentation (URS, FDS, SDS)
Qualification & Validation and CSV
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment and control systems
- Manage cleaning, process, and CSV validation in compliance with GMP and regulatory guidelines, Data integrity (ALCOA+)
- Maintain validation master plans and ensure lifecycle documentation (VMP, URS)
- Coordinate requalification and periodic review activities
Quality Assurance – Operations (QA Ops)
- Responsible for Deviations, CAPAs and Change Controls.
- Review Batch documentation
- Review root cause investigations (5 Whys, 5M/6M, GEMBA)
- Elaborate Quality strategies
Quality Assurance – System (QA System)
- Implement and maintain QMS (ISO 9001, ISO 13485, GMP, 21 CFR Part 820)
- Conduct audits (internal, external, suppliers) and manage documentation
- Ensure inspection readiness and regulatory compliance
- Manage training records and controlled documents
- Supplier Quality Assurance
Quality Control
- Development, validation, and transfer of analytical methods (ICH, Pharmacopoeias)
- In Process Control (IPC) and testing of raw materials, intermediates, and finished products (Analytical & microbiological testing)
- Perform environmental monitoring and lab equipment maintenance
Projects in action
See the projects where our consultants turn expertise into tangible results.
Qualification and Validation
The goal was to modernize infrastructure, upgrade equipment, and optimize manufacturing processes for injectable pharmaceuticals. To achieve this, the site underwent a complete shutdown of several weeks, allowing critical upgrades to be carried out.
Nalys consultants were deployed across key departments to support the site’s transformation:
Engineering: technical coordination, supplier management, and interface oversight
Qualification & Validation: drafting and execution of IQ/OQ/PQ protocols, deviation handling, and validation documentation
Process: flow optimization, review of critical parameters, and production support
Key Achievements
During the shutdown, our teams contributed to the successful execution of:
Installation of new production equipment
Renovation of buildings and technical utilities (HVAC, purified water, steam, etc.)
Upgrades to control systems and automation
Process adaptations to meet regulatory and standards
Results
Thanks to their expertise, precision, and ability to perform under pressure, Nalys consultants helped deliver all milestones on time, despite a tight schedule and strict compliance requirements. Their contribution ensured a smooth restart of the site, while maintaining the highest levels of quality, safety, and traceability.
OUR TEAM
Get to know the people behind Nalys
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