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.
Our services include the following areas:
- Project management of complex projects in the pharmaceutical sector
- Design of production facility and cleanroom for pharmaceutical production
- Process ventilation and refrigeration supply combined with the newest heat pump technology
- Design of process plants and process supply for pharmaceutical production
- Design and specification of “end of line” – from filling of the product to the final palletizing
- Process automation and building management systems
- Design and specification of process supply
- Energy counselling and specification of process supply
- Logistics, supply chain and serialization
- Masterplans, feasibility studies, due diligence and audits
- Design of laboratories