We offer strong expertise in pharmaceutical and medical device production suites.
We help you in designing, constructing, and qualifying new facilities and production lines. Our services encompass all investment phases, from creating a concept to delivering the final report.
We have long experience and extensive know-how, from the contained production of potent API to the biological manufacturing of vaccines.
We use agreed standards and guidelines as the basis and tailor the design according to your requirements.
A well-functioning production suite provides the basis for efficient production. We involve architects, engineers, operators and equipment suppliers to tailor cleanrooms according to your needs.
A cleanroom has multiple objectives. Primarily, it must protect the medicinal product from contamination and the operators from harmful substances. In addition, it must ensure an ergonomic work environment and accommodate the required equipment and utilities.
We have vast experience in cooperating with different cleanroom suppliers. Together we can define a cleanroom suitable for your operations.
Pharmaceuticals are produced in a variety of ways, depending on the medicine itself and the desired product. We have extensive experience and expertise in a wide range of production processes.
You can rely on our experience: we have designed several facilities with GMP approvals from the EU, FDA and local authorities.
We start by defining the critical parameters for the production process during the R&D and process development stages of the new pharmaceutical. Based on these, we design the complete production process with the automation system.
Compliance with regulations
The manufacturing of pharmaceuticals is highly regulated. We help you navigate through the requirements and tailor facilities according to your needs.
The production of pharmaceuticals and medical devices requires vast knowledge of regulations, standards and guidelines. We have completed pharmaceutical investment projects around the world and can guarantee you expert service.
Facilities we have designed have received Good Manufacturing Practices (GMP) approval by the European Medicines Agency, World Health Organization and US Food and Drug Administration.
All investment projects require planning. By working together, we can issue a project execution plan and schedule to ensure that your project is completed on time and on budget.
We manage projects of all sizes, from small designs to turnkey projects. Our project management always includes scheduling, resourcing and budgeting. In addition, we can help with requests for offers, selecting suppliers, contracts, procurement, installation and commissioning. If you wish, we can also provide you with a project manager or director with experience in delivery and installation supervision, testing, commissioning and inspections.
With the EPCM delivery method, you acquire project management services related to Engineering, Procurement and Construction Management from us, but you enter into contracts directly with suppliers. With the EPC delivery method, you get the entire implementation of the project, including Engineering, Procurement and Construction. In a distributed project, you manage the coordination of the project’s various sub-assemblies yourself.