Haselmeier is a leading developer and manufacturer of innovative self-injection devices featuring proprietary designs, technology and intellectual property (IP).
With more than four decades of medical device experience, Haselmeier has built up a world-class design and development team that works in compliance with regulatory requirements for the creation, design and industrialisation of our innovative self-injection systems used by pharmaceutical and biotechnology companies worldwide.
Headquartered in Switzerland, the Haselmeier Group employs approximately 200 team members worldwide and has a presence in Europe, the US, India and China.
Products are manufactured at state-of-the-art manufacturing sites located in Buchen im Odenwald (Germany), Dnesice (Czech Republic) and Bangalore (India).
Haselmeier’s mission is to create products enabling a convenient and comfortable experience. This is why patient feedback is integrated early in our device designs.
Early concepts are prototyped for testing and Human Factors studies to capture the handling needs and skills of potential users. This knowledge is integrated into the device design to provide successful administration of the drug product and a positive user experience.
Haselmeier offers a range of early-stage activities:
• Think-tank discussions and paper concepts
• Detailed product concepts and industrial designs
• Detailed user handling review and risk-analysis
• Prototyping of initial concepts up to functional devices
• User focus groups and human factors studies for concept and prototype evaluations
• Detailed user requirements and product design specifications based on selected concept
Successful development and industrialization of drug delivery devices is dependent upon the understanding and execution of today’s technical, regulatory and operational requirements.
At Haselmeier we provide integrated design, development and industrialization services to help you bridge your serial product into the market. Our qualified design control process, certified quality system, regulatory expertise, solid network of partners and strong manufacturing operations are all designed to achieve your expectations. Together we enable a smooth market introduction for your commercial drug delivery device.
Haselmeier’s commercial development and industrialization services include:
• Concept transfer into detailed user requirements and product design specifications
• A certified design control process and quality system
• Design verification, product and process validation processes
• Regulatory expertise to support your approval strategy
• Controlled design-to-manufacturing transfer, verification and validation
We understand that each customer has individual and specific requirements for their product. Regardless of your requirements, Haselmeier applies the highest standard for manufacturing your drug delivery device to ensure a reliable and reproducible manufacturing and quality process. We work continuously with our customers to identify product improvements at all stages of the product’s lifecycle to provide a safe and state-of-the-art drug delivery device.
Haselmeier provides flexible, reliable, manufacturing and lifecycle management:
• Certified and modern production facilities and manufacturing processes
• Qualified and well-trained personnel
• A strong network of sub-suppliers and manufacturing partners
• Continuous engineering and product improvement program
• Innovation meetings to identify next product generation
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