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Marek Kalmus Consulting is a specialized life sciences consultancy based in Germany, providing strategic and operational support in regulatory affairs, quality management, and clinical development. Led by Marek Kalmus, the firm assists biotechnology and pharmaceutical companies in navigating complex European and international regulatory landscapes, ensuring compliance with GxP standards. Their services include auditing, preparation of regulatory submissions, and the implementation of quality management systems. The consultancy is particularly active in the DACH region, supporting both emerging startups and established healthcare entities. It has significant expertise in Advanced Therapy Medicinal Products (ATMPs) and regenerative medicine.
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