ABOUT GALENODERM 

Galenoderm is a distinguished chemical-pharmaceutical company based in Slovakia, rooted in a tradition of excellence since 1934. The company thrives on its robust capabilities in the development, production, and marketing of two primary product groups: active pharmaceutical ingredients and chemical intermediates and specialties. With a strategic focus on exports, Galenoderm serves a global client base, delivering products across the EU, USA, India, Japan, and Latin America.

Historical Milestones of Galenoderm

  • 1934: Initiation of industrial chemical production, marked by the construction of a modern facility.
  • 1952: Became independent and expanded to include veterinary drug production.
  • 1992: Transition to a joint-stock company, emphasizing family-owned management.
  • 1996: Major restructuring and expansion of the product line driven by innovative R&D outcomes.
  • 1997: Significant flood incident causing a temporary halt in production.
  • 1998: First US FDA inspection, pivotal for entry into the US pharmaceutical market.
  • 2004 and beyond: Continued expansion with new facilities and units to enhance production capacity and compliance with global standards.

Galenoderm remains committed to leveraging its extensive R&D expertise to pioneer new chemical procedures, ensuring its products meet the highest standards of quality and innovation. This commitment is evident in their patented processes recognized in the Czech Republic, Europe, and the USA, underscoring their leadership in the pharmaceutical sector.

Quality system

The quality section consists of two parts – the Quality Control (QC) department and the Quality Assurance (QA) department. QC primarily ensures the use of suitable raw materials and products, the setting of appropriate analytical specifications for individual stages of production and the performance of all analyses. The main responsibilities of QA are checking and approving company processes, checking record documentation, conducting audits, trending achieved results or releasing finished products.

 

The quality of the products produced in our company is further ensured by an implemented quality assurance system that meets the current requirements of ISO 9001 and Good Manufacturing Practice for the Production of Medicinal Substances (cGMP). Because the quality system connects all departments in the company through the production process, from purchasing to the release of the finished product, its active maintenance is an important part of our corporate culture.

 

The quality section also emphasizes the implementation of the latest knowledge of cGMP, ISO and ICH regulations into the company system in order to achieve the maximum use of modern quality management tools.