Front-end Decision Design

At ManEx, we enable our client to make critical business decisions in the early stage of his investment project. We do this by understanding the requirements and challenges and then unlock the value and potential in his project by creating a solid foundation for making decisions and creating the suitable design.

Facility Design

With many years of experience, especially in the pharma industry, our broad expertise and interdisciplinary approach to facility design enables us to deliver holistic solutions, ensuring compliance, sustainability and logistics support the manufacturing process in the best possible way.

Process Engineering

Project Management

We have a number of tools in place which aim to ensure efficient and consistent execution of the project, in a way that counteracts the typical concerns voiced by our clients, so there are always:

• Good alignment of scope between customer and vendor.
• Clear communication between customer and vendor.
• Sufficient risk assessment.
• Sufficient quality control activities.
• Optimal knowledge-sharing within and between project teams.
• Effective handling of scope creep or scope changes.

Acceptance Tests & Commissioning

Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment; we can support our client in developing his FAT and SAT plans, executing them, and maintaining integrity throughout the process.

GMP & Compliance

ManEx consultants and engineers help the clients achieve and maintain GMP compliance throughout the lifecycle of a product by delivering customized compliance services; this includes:

• GMP strategy development.
• GMP compliance training.
• Quality support on optimization, implementation and training.
• Audits and validation documentation (IQ/OQ/PQ Protocols).

Automation & IT

We can design, implement and optimize flexible automation and IT systems to control equipment and processes and manage information; this includes:

• Process control system (SCADA, PLC).
• Building control system (BMS, FMS).
• Enterprise resource planning system (ERP).
• Systems infrastructure.

Regulatory Support

We offer regulatory affairs services for our manufacturing clients to help minimize product development time and accelerate product approval. Our experts can provide guidance and potential solutions to regulatory hurdles.

Technical Support

Factories may encounter technical issues in their machines or sometimes variations in a product quality; ManEx engineers can provide rapid on-site support to help a client rectify problems.