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EMCM Business Case

European Medical Contract Manufacturing (EMCM) in Nijmegen specializes in the development and production of sterile medical products. Founded in 1993, EMCM operates in accordance with GMP and ISO standards and offers comprehensive contract manufacturing services. In addition to liquids, the company also produces suspensions, gels, and powders, which are packaged in ampoules, vials, syringes, sachets, and bottles. EMCM focuses on delivering high-quality products and serves the global market.

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Apurv Sinha, Manager of Project Engineering and Maintenance, is responsible for all client and internal projects, including maintenance activities, validations, and facilities management. He initially engaged Yxion because specific expertise was needed and the current team was too busy with ongoing projects. After just a few months, the decision to choose Yxion has proven to be a huge success.

 

Out of the box

“Yxion has expertise in the entire process development, from the first feasibility batch to the final validation batch. In addition, they have consultants responsible for Container Closure Integrity studies, cleaning validations, and the overall implementation of the process. This allows them to collaborate effectively with EMCM’s specialists, resulting in practical, immediately deployable ‘out-of-the-box’ solutions.”

“Because project and process engineers work closely together, they ensure a seamless implementation of new processes and equipment. Yxion’s consultants are able to respond quickly to our needs and provide the solutions necessary to ensure this project runs efficiently. They can be deployed based on both their knowledge and their experience and offer additional expertise in areas such as the new Annex 1 and ISO 13408. Consequently, they are able to achieve and guarantee the highest quality standards.”

 

Immediate Added Value

“The collaboration with the consultants has been very positive. They quickly familiarize themselves with our processes and have a deep understanding of the regulations. Unlike hiring someone without experience, the Yxion team delivers immediate added value. Their technical knowledge and ability to support decisions with thorough research are invaluable.”

“When I need someone, I call Katja or David. They always have a consultant who can help me. We will continue to work together in the future. Their professional approach and expertise are indispensable to the success of our projects. Yxion’s responsiveness and the seamless coordination among consultants remain exceptional.”

 

Working Together Toward Tangible Results

Innovating Together

We help clients innovate by proposing new ideas and improving processes, equipment, environments, and services. Our consultants possess a wealth of knowledge. Together, we have the right answer to every question, no matter how complex.

Sharing knowledge

During the Yxion Academy and professional groups, colleagues come together to exchange knowledge and experiences and discuss current developments. To brainstorm together about client questions and determine which training programs align with their own needs and those of the clients. In short: to learn from and with one another.

Part of a Close-Knit Team

Of course, in addition to working hard, we also have fun. We love organizing outings for the entire organization—activities such as bike rides, a trip to Winter Efteling, European Championship pool tournaments, dinners, and barbecues. These are moments to relax and catch up with colleagues!

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Yxion offers the following services:

Commissioning, Qualification, and Validation (CQV)

GxP Compliance and Auditing

Medical Team Performing Surgical Operation in Bright Modern Operating Room

Quality Management System (QMS)

Program and Project Management

Cleanroom Implementation and Validation with CLIMB®

Cleanroom Validation

Cleanroom commissioning and maintenance

Interim Professionals

Subject Matter Experts (SMEs)

Project and programme management

QMS development and optimisation

Programme and project management

Staffing support and training

Customized Training

Your partner in quality, safety, and compliance

The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.