Our core competencies as a management consultant comprise total quality management, human resources and organisational development. Therefore, we will assist you in all compliance issues with our knowledge and expertise.

We see ourselves as a transfer center for quality with a global view and focus on the medical device and pharmaceutical industries. Our area of competence also includes suppliers to the aforementioned industries such as Health Care Services and Clinics. Our services range from the implementation of quality management systems  (ISO 900X, 13485, 2000X, FDA 21 CFR Parts 11, 210, 211, 820 and EU-GMP) to the qualification / validation of IT-systems (e.g. ERP-systems) and production and laboratory systems. In recent years the qualification of IT-infrastructures and the implementation of IT-security systems have gained increasing importance. We feel that our “contract” from the customer is to provide a thorough knowledge transfer concerning the methodologies we employ in achieving our main goal, that of compliance. In creating transparent and conform company and business processes we are able to eliminate compliance deficits. This is supported by creating and extending organizational methodologies such as standards, methods and policies.

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