HemAcure - Team
HemAcure - Team
HemAcure - Team

Partner 2 - GRU - Grünewald GmbH Co. KG

 

Martin Zierau

Dipl.-Ing. Martin Zierau

 

Project Leader

Leader WP6

 

Phone: +49 6252 67079-0

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GRU - Grünewald GmbH & Co. KG

 

Spessartstr. 2

64646 Heppenheim

Germany

 

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HemAcure Team GRU - Grünewald GmbH & Co. KG

 

Samim Azizi

 

Project Manager

 

Phone: +49 6252 67079 – 0

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Institute presentation

The Grünewald GmbH & Co. KG was founded in 1999 as IMS e.K. and is a well-known service provider for quality management in life science industries. Its customers range from small and medium sized enterprises up to global companies, e.g. Roche, Sanofi, Pfizer, Zimmer, Fresenius, BBraun etc. The company offers customized support on implementing effective quality management processes and methods in compliance with GMP-guidelines. It is specialized in efficiently aligning product specialists of pharmaceutical industries as well as medical device industries to the requirements of regulatory compliance. Typical projects deal with key topics of development activities and the design transfer, with analyzing production and quality assurance processes and creating the associated SOPs (Standard Operating Procedure Descriptions), with the qualification and validation of systems and processes, with the implementation of risk management systems and with implementing statistical methods for process improvement. The Grünewald team researches methodical requirements to achieve GMP conformity from the very beginning of a multinational biopharmaceutical development project. It is intended to enhance the quality of the development process itself as well as to develop the required tools for an efficient design transfer into production. The GMP approach aims to identify and to define the critical attributes of each manufacturing step, including inputs (i.e. materials, information), task characteristics (e.g. equipment, process parameters, disturbing effects) and manufacturing results (materials, information). Grünewald GmbH & Co. KG produce major outcome in our projects like “GMP conformity” tool sets. They enable SMEs to improve the efficiency and the quality of their development of biopharmaceutical products as well as to conduct a cost-efficient design transfer. The focus of projects is always driven by achieving maximum efficiency and effectivity.

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