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

  • Scope Definition, Quality, Cost forecast, Planning Management, Leadership,
  • Reporting, Stakeholder Management, Risk Management
  • 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
  • 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
  • Support design, implementation/integration, and troubleshooting of automated systems (SCADA, PLC, DCS)
  • Develop and maintain automation documentation (URS, FDS, SDS)
  • 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
  • Responsible for Deviations, CAPAs and Change Controls.
  • Review Batch documentation
  • Review root cause investigations (5 Whys, 5M/6M, GEMBA)
  • Elaborate Quality strategies
  • 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
  • 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.

OUR TEAM

Get to know the people behind Nalys

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Jimmy

Business Unit Director

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Alexandre

Business Unit Director

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Olivia

Talent Acquisition Specialist

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Martin

Operations Director

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Fatoumata

Business Manager

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Nathan

Business Manager

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Anna

Talent Acquisition Specialist

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