One of the fastest growing Switzerland based pharmaceutical company was facing issues in filing of variations for atracurium solution for injection product registered in Switzerland and it approached Freyr to resolve the issue. Insufficient supporting data was available for the proposed variations, which posed to be one of the major challenges for Freyr. The Regulatory affairs team at Freyr leveraged their expertise to quickly perform a Gap Analysis and provided minute detailed justification for each variation category proposed and variation filing strategy was planned according to the availability of the documents, which reduced much work at the manufacturing site.
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