Milestones to Markets

We help you achieve your regulatory development objectives

Focus on US FDA regulation insight strategy and support

Areas of expertise: pharmaceutical, biologics and advanced therapies

US Agent regulatory services for foreign firms

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.

Our Services

  • 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

Learn More

“Our goal is to help you achieve your regulatory development objectives and get your products to the market faster.”