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Gib hier deine Überschrift ein
Gib hier deine Überschrift ein
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We have a proven history of successful pharma technology transfer at all phases, with professional project management, technical and operational expertise to support even the most complex transfer requirements.
Our qualified and highly skilled team, exposed to international quality standards and experienced in manufacturing for third-party customers, will support you at every stage during technology transfers.
Design and construction
Globalization and pandemics have brought critical challenges for our customers, but also opened new opportunities to establish production facilities based on innovative goods and technologies, for example in the manufacturing of sterile products, high potency products, biosimilars, human plasma and vaccines.
Through our expertise in project management, design and engineering we support our customers to overcome these challenges.
A strong network is the key for the success in the execution of this kind of projects.
We provide a full range of expertise in quality assurance, quality system management, technical services, and operational excellence. Our expansive suite of services ensure quality, compliance, efficiency, and safety throughout the full lifecycle of a product.
We work with our clients to obtain production permits from regulatory agencies. This requires both regulatory compliance and certification of your process with full documentation.
During the course of our engagement, we continually educate your team to facilitate knowledge transfer and ensure long-term sustainability of quality enhancements.
Regulatory affairs & compliance
We enabled preparation for a major regulatory inspection by conducting a complete lifecycle management of the inspection readiness and associated change management activities through communication and stakeholder management.
Our Quality & Compliance experts support you with the highest quality of services, step by step by providing best practices and proven insights on program and process management to obtain EU/FDA/PIC GMP certification.
Take advantage of our comprehensive experience in the area of inspections to prepare you for the inspection of health authorities.
