XP Forte Regulatory Limited

XP Forte has a network of regulatory professionals with its core team having over 70 years of regulatory experience across therapeutic areas. They have expertise in devising global drug development strategies, Drug Development, Orphan designations, Paediatrics (PIPs), ATMPs, oral hearings, Medical Device and global submissions: MAAs, BLAs, Canada, Japan, Latin America and Middle East & Africa (translations and Q&A). Furthermore they excel at Life Cycle Development, Therapeutic areas. Extensive involvement in Patient Advocacy working on expert panels on patient ethics and access. They are considered the place to go for regulatory problem-solving commercial supply.