Global Regulatory Support

With our deep experience navigating global compliance requirements, we can provide expert guidance to help you execute your clinical and commercial regulatory strategies and prepare your regulatory filings for submissions around the world, including:

• New drug applications
• Biologic license applications
• Investigational new drug applications
• Abbreviated new drug applications
• Marketing authorization applications
• Drug master files
• Site master files
• Drug listings

We offer extensive regulatory support, resulting from our knowledge of global compliance standards.