Quality Change goes international in South Korea

Bresewitz, Germany: – For pharma companies operating in international markets, it is vital to have in-depth knowledge of regional variations in regulation and market expectations. For instance, standards relating to Good Manufacturing Practice (GMP) differ between Europe and South Korea, a highly sophisticated and economically significant pharma market in its own right.

Accordingly, a team from Innovative pharma industry quality management specialists Qualitätswandel Dana Graupner is embarking on a business familiarization tour of South Korea.

Strategic importance

Qualitätswandel sees the trip as strategically important to expand its knowledge base and networks to support client companies in expanding into the Korean market, to open new applications for its regulatory and quality management expertise, and to gain benchmarking insights into regulatory best practice in this advanced Asian pharma arena.

The trip is supported by the German Government and Administrative Economic Ministry and organised by the Cologne-based international co-operation agency trAIDe GmbH.

The Qualitätswandel team, including Managing Director Dana Graupner,with consultants Stefania Kincler and Elisabeth Lieschke, will be in South Korea from 27^th June – 4^th July. Their schedule will include an initial cultural and market briefing from the German trade mission and local pharma experts in Seoul,  a political briefing at the German Embassy, a presentational event to manufacturers active in the Korean market, and a series of B2B meetings and company site visits.

Korean inspiration

Dana Graupner commented: “We are ready for inspiration, exchange and growth and South Korea is a hotspot for innovation, technology and forward-thinking entrepreneurship. This is a superb opportunity to set new impulses, forge strong partnerships and bring our quality change expertise to the global stage.”

“South Korea is an up-and-coming market and supplier of both pharmaceuticals and medical devices, with many Korean cosmetics approved as medical devices, for instance,” she noted.

“Our preparations are in full swing and our presentations are sharpened to inspire on site,” Dana added.

About Qualitätswandel Dana Graupner

Qualitätswandel Dana Graupner GmbH is a consultancy organization that helps companies, including those in the pharma and life sciences sectors make process transformations that require re-engineered quality management systems.

The company’s ‘Quality Transformation’ name encapsulates its mission to optimize quality management at organizational and systems levels. The company leverages its deep-rooted GMP and ISO expertise to help clients navigate the highly complex quality assurance landscape and achieve their goals. Its wide-ranging services include developing a GMP quality management system (GMP), ISO 9001 and ISO 13485, process analysis, training and audits.

The company offers customized services highly tailored to the individual needs of  pharmaceutical and medical product manufacturers, as well as to clinical and pharmacy organisations, drawing on deep expertise QM systems, project management, regulatory affairs management, documentation, cleanroom technology, risk assessment, and GAMP 5 CSV Computer Systems Validation.

Founded in 2019 by pharmaceutical quality expert Dana Graupner, Qualitätswandel is based at Bresewitz on Northern Germany’s Mecklenburg-Vorpommern Baltic Coast, with team members located all over Germany and connected online.

In its few years of operation, the company has already conducted scores of successful engagements, currently lists more than 40 client companies, and has been honored with top consultancy awards for 2023 and 2024.

Resources

Click on Qualitätswandel in South Korea to learn more.
Click on About trAIDe for further information.
Click on Advice through Leadership to watch video.