Who We Are
REGULIANCE is a consulting firm focused on US FDA regulatory affairs for pharmaceutical and biopharmaceutical development and commercialization. Founded in 2002, Reguliance provides an array of services including FDA regulatory insight, strategy, and support, to small- and medium-size domestic and foreign companies.
Reguliance is the US Agent for a number of foreign pharmaceutical and biopharmaceutical companies providing representation for US orphan drug applications, IND applications, drug and biologic master files (DMFs), and facilities registrations.
- US Regulatory Affairs Support for New Drugs (NDAs), Generic Drugs (ANDAs), Biologics (BLAs) including Advanced Therapies, and Combination Products
- US Agent Services for Foreign Firms
- Specialized Regulatory Assistance for Startup Companies
- Regulatory Due Diligence for Licensing and Acquisition