ECD Life Sciences (ECDLS) serves as the official U.S. Agent for foreign biotechnology and pharmaceutical sponsors submitting Investigational New Drug (IND) applications to the FDA. When an IND is signed by a person who does not reside or maintain a place of business in the United States, the application must identify—and be countersigned by—a U.S.-based attorney, agent, or other authorized official.

As your U.S. Agent, ECD Life Sciences provides a secure, responsive U.S.-based point of contact for FDA correspondence and IND-related communications. We receive and monitor Agency communications, notify your team promptly, and coordinate appropriate follow-up.

ECD Lifee Sciences can publish your regulatory documents in electronic Common Technical Document (eCTD) format and submit INDs, amendments, annual reports, safety reports, and other applicable regulatory documents through the FDA Electronic Submissions Gateway (ESG).

Our support can include:

• U.S. Agent designation and IND countersignature support, as appropriate.
• Secure receipt, monitoring, and management of FDA correspondence.
• Prompt coordination of FDA information requests and sponsor responses.
• eCTD publishing and quality review of submission-ready documents.
• Electronic submission through the FDA ESG.
• Initial IND submission support and ongoing IND maintenance.

ECDLS combines U.S. Agent representation with practical drug-development expertise. Rather than simply receiving FDA correspondence, our senior-level team can help your organization assess and address the scientific, regulatory, clinical, CMC, and safety issues that may accompany Agency requests.

We provide flexible access to integrated support across regulatory affairs, program strategy, clinical development, clinical operations, clinical pharmacology, pharmacovigilance and medical monitoring, CMC advisory, medical writing, and specialized subject-matter expertise. ECDLS works as an extension of your team, with engagements led by experienced principals.

U.S. FDA Agent Services are offered on a monthly-fee basis, with scope and pricing tailored to your program stage, anticipated submission activity, and FDA communication needs. Broader regulatory, clinical, and drug-development support can be added as needed through flexible project, retainer, or advisory arrangements

Complete the contact form to learn more about ECDLS U.S. FDA Agent Services, eCTD publishing, FDA ESG submission support, and monthly pricing. We will respond within 24 hours..