Since 2002, Reguliance provides US regulatory consulting services to small- and medium-size pharmaceutical and biopharmaceutical companies. Reguliance address the needs of startups and early development firms by becoming their “external employee” and an integral team player.

Areas of expertise include:
 

• 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