Services
our services
At the heart of any successful project lies a well-crafted management strategy. With our team of seasoned management experts, we embark on your project journey from day one, meticulously crafting a strategy that not only oversees every task but also establishes an efficient leadership structure for the entire project team. This unwavering commitment ensures not just the start, but the successful completion of your project.
Our management activities span a wide spectrum, encompassing:
- Leading of all project disciplines
- Project scheduling and control
- Cost evaluation, control and monitoring
- Project risk assessments
- Procurement strategy
Document Management
Empowered by our Good Document Management Practice, we guarantee:
- The seamless implementation of a robust document management system within your project.
- A secure and unbroken document flow for all stakeholders involved.
- Precise control over the upload, distribution, and secure archiving of files.
- Real-time visualization of document progress.
- Full, unambiguous control over document status throughout the project lifecycle, from creation, to review, and final approval.
Process and Design Engineering
At the core of our process engineers' approach lies the fundamental principle of meticulously defining, expertly implementing, and optimizing design.
- Define GMP compliant design of equipment and room
- Optimize personal and material flows to fulfill all containment aspects for personal and product protection
- Evaluate concepts to improve existing processes or to establish new processes
- Visualize processes with simulation tools
We possess the capability to expertly oversee and handle:
- Process simulations and scale-up’s
- Process Flow Diagrams (PFD)
- Layout visualization
- Piping & Instrumentation diagrams (P&Ids)
Architecture
Our team of dedicated engineers collaborates seamlessly with architects, whether it’s crafting innovative designs for new structures or professionally modifying interior spaces to meet project-specific demands.
We take pride in fostering a harmonious partnership, facilitating close collaboration among architects, civil engineers, and all involved disciplines, to seamlessly tackle the entire spectrum of project requirements.
- Greenfield or brownfield approach
- Review of Site Master Plan including access, routes and flows
- Control of architectural documents
- Building statical calculation, layouts, building section views, floor loading plans
- All Cleanroom engineering activities
- Accompaniment of regulatory reviews
Media and Infrastructure
Our experts for media and infrastructure needs of the building lead, control and coordinate the following disciplines of:
HVAC
- Definition of HVAC design
- Room pressure and Zoning layouts
- Preparation of room list
- Fix of room design criteria
- Routing and duct layouts
- Preparation of full document package (Data sheets/Technical description/etc.)
Definition of Sanitary needs
- Potable water
- Emergency systems
- Wastewater treatment
Definition of Black and Clean media supply
- Purified water
- Water for Injection
- Black and clean steam
- Cooling water
- Compressed air
- Process waster water
E&IC/Automation
- High / Low voltage
- Room monitoring
- Building Management System
Qualification and Comissioning
With our awareness of the current GMP regulations and guidelines as well as with the integration of the workload into the project schedule we can manage:
- GMP Risk assessments
- cGMP design reviews
- FAT/SAT assistance
- Preparation of full CQV document package
- Execution of Qualification works (DQ, IQ, OQ)