Bringing a program to the Food and Drug Administration (FDA) from outside the country requires a United States-based agent. ECD Life Sciences offers two ways to meet that requirement.

• If you have internal regulatory capability and need a responsive U.S. point of contact, our standalone U.S. FDA Agent service covers designation, IND countersignature, FDA correspondence, and electronic submissions on a monthly fee.
• If you are filing your first U.S. IND, we can build and submit the application with you - regulatory strategy, pre-IND meeting preparation, authoring, eCTD publishing, ongoing FDA engagement, and full support as your U.S. Agent.

Whichever route you choose, you are led personally by our principal, a drug development physician with more than 25 years of industry experience and multiple successful IND filings.