NIRAS is Denmark's leading independent consultant when it comes to design and operation of Pharma & Life Science production facilities. We help create a decision-making basis for investments. We design buildings and production facilities, and we ensure compliance with cGxP and optimize facilities and quality systems.
NIRAS is the professional, independent consultant when it comes to pharma and life science investments, project implementation, and optimisation of production plants.
Based on our in-depth knowledge of pharmaceutical products and processes, we can translate visions and challenges into sustainable solutions - from initial idea to a fully operational, validated plant.
We advise some of the largest manufacturers in the world on optimisation of the value chain, adaption of capacity needs and cGxP compliance, thereby strengthening our customers' competitive position in the market.
Our interdisciplinary and agile approach to the solutions integrates functionality, design and economy with long-term development.
Our services cover the whole spectrum of tasks from “no impact” to “direct impact” projects. We act amenably with a strict focus on our clients’ needs.
Our GMP competencies are based on a solid base of references as well as a series of specialists who have many years of experience from the pharmaceutical sector. Our level of expertise ranges from generalists to highly estimated experts.
Projects are being carried out in close cooperation between GMP specialists and experts within process equipment and supply systems, process ventilation and design of production facilities, including design of cleanrooms.
The task of qualification and validation form a natural and parallel part of all projects with impact on the final product. NIRAS is also recognized for its ample knowledge of the food and beverage industry which inspires us to find new, innovative and effective solutions
NIRAS assists in the process of creating and optimizing the internal quality systems of pharmaceutical manufacturers.
The systems are made in such a manner that they are in compliance with the applicable regulatory requirements, and additionally they are customized to the requirements and needs of the respective manufacturers.
In NIRAS, we emphasize pursuing the United Nations 17 Sustainable Development Goals (SDG) in targeted manner. On one hand, we have a series of tools that focus on relevant objectives, on the other hand we solve our tasks with a focus on finding optimal solutions.
In addition, we combine our experience within GMP production with our specialists within energy consulting and management.
Compliance
Regulatory Affairs Good Manufacturing Practice GMP Quality Assurance (QA) Translation and proofreadingPlanning
Master Plans, Feasibility Studies, Due Diligence and Audits Supply Chain Optimisation, Logistics and Automation Project managementDesign
Design of Classified Production Areas Design of process plants and equipment for pharmaceutical production Laboratory Design IT and Automation End-of-Line Solutions from Packaging to Palletising Energy-Optimised Process Utility Ventilation and Cooling SupplyEducation & Courses
NIRAS Life Science Academy
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