Life science companies are facing increasing pressure to deliver high-quality products, ensure regulatory compliance, and scale production in a rapidly evolving environment.
Life science manufacturers must increase production capacity, maintain regulatory compliance, and accelerate delivery timelines while ensuring product quality and patient safety. AFRY helps organizations achieve these goals through integrated engineering, quality, digitalization, and project delivery services across the entire facility lifecycle.
We provide engineering solutions for the life science industry
Key challenges in life science today
The life science industry is evolving rapidly, driven by increasing regulatory expectations, digital transformation, environmental topics, safety and the need to scale production without compromising quality.
Today, organizations are facing several interconnected challenges across their operations:
- Strengthening quality and compliance capabilities, where GMP and contamination control strategies must be embedded into daily operations rather than handled as standalone requirements
- Designing and operating efficient cleanroom environments, balancing contamination control, airflow performance, and operational efficiency
- Managing validation and digital systems, ensuring data integrity while transitioning from paper-based processes to continuous, lifecycle-based validation
- Optimizing production and manufacturing performance, enabling scalable, efficient operations that support growth and sustainability
- Integrating engineering, quality, and digital solutions to reduce complexity and improve decision-making
- Management and delivery of multidiscipline turn key deliveries
The organizations that succeed are those that take a proactive, data-driven approach, integrating engineering, quality, and operations to build resilient and future-ready manufacturing environments.
Why AFRY
- More than 1,500 life science experts globally
- Over 500 pharmaceutical specialists
- Expertise across engineering, quality, validation, and digitalization
- Global delivery model with local execution capabilities
- End-to-end support from concept design through operations
- Proven experience delivering GMP-compliant facilities and manufacturing environments
How AFRY supports life science clients
Our services cover every stage of your plant life cycle, from initial pre-studies and CAPEX investments to ongoing operational support. By identifying and implementing the Best Available Technology (BAT) and applying a risk-based approach throughout the project lifecycle, we help our clients ensure product quality, patient safety, data integrity, and regulatory compliance while transforming complex challenges into high-performing solutions.
- Engineering and plant design
- Commissioning, Qualification, and Validation (CQV)
- Quality and compliance advisory
- Cleanroom and contamination control strategy
- Digitalization and data integrity
We provide multidisciplinary engineering and plant design services tailored to the specific requirements of the life science industry. Our expertise covers process design, plant engineering, automation, process architectural, building construction and infrastructure systems, ensuring that production facilities are safe, efficient, scalable, and compliant with regulatory standards. From concept development to detailed design, we support our clients in creating facilities that meet both current and future operational needs.
Our CQV specialists ensure that facilities, systems, equipment, and processes are installed and operated according to predefined requirements. We manage and execute commissioning, qualification, and validation activities throughout the project lifecycle, helping clients demonstrate compliance with GMP and other regulatory requirements while minimizing risks and accelerating time to market.
We support organizations in establishing and maintaining robust quality systems that meet global regulatory expectations. Our advisory services cover GMP compliance, quality management systems, audits, inspections, risk assessments, and regulatory strategies. By combining industry expertise with practical solutions, we help clients strengthen quality performance and maintain operational excellence.
Maintaining product quality and patient safety requires effective contamination control. We assist clients in designing, optimizing, and monitoring cleanroom environments and contamination control programs. Our services include cleanroom classification, environmental monitoring strategies, airflow studies, contamination risk assessments, and implementation of contamination control measures in line with the industry’s best practices and regulatory guidelines.
We help life science companies leverage digital technologies to improve operational efficiency, product quality, and regulatory compliance. Our expertise includes digital transformation, manufacturing execution systems (MES), automation, data management, and data integrity programs. We support the implementation of secure, reliable, and compliant digital solutions that enable data-driven decision-making and ensure compliance with regulations such as GxP and ALCOA+ principles.
A trusted partner for future-ready life science manufacturing
As life science manufacturing continues to evolve, organizations need partners who can navigate increasing regulatory requirements, technological advancements, and growing production demands. AFRY combines deep industry expertise with multidisciplinary engineering, quality, validation, and digital capabilities to support clients throughout the entire facility lifecycle.
Whether developing new production facilities, modernizing existing operations, or improving manufacturing performance, we help our clients reduce complexity, manage risk, and deliver compliant and efficient solutions. By combining engineering, quality, digitalization, and project execution under one delivery model, AFRY helps life science manufacturers reduce project complexity, accelerate delivery, maintain compliance, and create facilities that are ready for future growth.
