Intended Cooperation
- Main focus on Korean manufacturers looking to expand to the German or European market.
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- Seeking mutually beneficial partnerships with local consulting firms in Korea — not only to bridge language barriers, but also to combine regulatory expertise and expand market reach
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- Collaboration with small and medium-sized pharmaceutical, biopharmaceutical, ATMP, and medical device manufacturers
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Products/Services
- Pharma Consulting & Compliance: Expert guidance on GMP and ISO standards to enhance quality management in the pharmaceutical industry
- Quality Management Systems: Design and implementation of customized QMS tailored to company-specific needs
- Regulatory Affairs & Audits: Support with regulatory compliance, internal audits, CAPA management, and preparation for inspections.
- Training & Ongoing Support: Practical training and continuous assistance to ensure effective QMS maintenance.
- Digitalization & Cleanroom Services: Implementation of digital quality tools, cleanroom qualification, and environmental monitoring.
Qualitätswandel GmbH provides tailored quality management solutions for the pharmaceutical industry, focusing on GMP and ISO compliance, regulatory affairs, audits, training, cleanroom qualification, and digitalization.
Their services aim to optimize operational efficiency and ensure regulatory compliance across all quality-related processes
- Dana Graupner
- graupner@qualitaetswandel.de
- +49 1732008291
- www-qualitaetswandel.de
Arrange an appointment for an
initial consultation
Are you interested in one of our projects? Then book a consultation now. We will be happy to present the project to you.
Philip Okito
General Manager and Co-Founder
- service@traide.de
- + 4922193544511
- Hohenstaufenring 42, 50674 Köln
free of charge & without obligation