Case Study: an Italian multinational pharmaceutical company achieves EU and USA market entry with FREYR regulatory strategy

Italian Multinational Pharmaceutical Company reduces submission effort with FREYR

The customer, an Italian multinational pharmaceutical company, sought to enter the EU and US markets with an innovator product for arthritis and muscular dystrophy but lacked internal expertise in FDA and EMA regulatory requirements, IND oversight, and pre-submission activities. FREYR provided an end-to-end regulatory strategy and submission support to address these challenges.

FREYR implemented a comprehensive solution that included regulatory gap analysis, health authority interaction support, and the preparation and submission of NDA, MAA, and DMF packages. This accelerated the approval process, reduced submission effort through content reuse, and ensured ongoing IND compliance. As a result, FREYR enabled the client's successful market entry and established a repeatable regulatory framework for future product launches.