Obtaining Swiss Trade Abroad Licenses for Three US Headquartered Biopharmaceutical Companies
Three sister US biopharmaceutical companies focused on the development of novel therapies in the areas of oncology, urology, women’s health, and a tissue-engineered (ATMP) product for a rare disease were interested in obtaining Swiss Establishment Licenses in order to operate from Switzerland and trade their products abroad.
For these time-pressured projects, the SFL Quality Assurance (QA) team identified and applied for Establishment Licenses that corresponded to each company`s needs while performing all the necessary inspection preparation activities for the three companies simultaneously, including gap assessment of each Quality Management System (QMS), updating of key global SOPs and drafting of tailored Swiss documents (e.g., SOPs, Site Master Files, Quality Agreements). The SFL QA team successfully hosted initial inspections for the three companies which were held over a period of one and a half months and managed to obtain Swiss Establishment Licenses for all three companies within 7 months.
After the inspections, SFL also provided oversight over the GxP operations of the three companies in the role as Swiss Responsible Person and Deputy Responsible Person and managed correspondence with Swissmedic and regional inspectorates.
The clients were highly satisfied with the outcome and SFL`s services and were able to initiate the activities in Switzerland.