United States FDA Agent Services for Clinical Trials and IND Sponsors
Your U.S. Agent for FDA IND Submissions
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 and/or conducting clinical trials in the United States under a U.S. IND. When an IND applicant resides or maintains a place of business outside the United States, the application must identify—and be countersigned by—a U.S.-based attorney, agent, or other authorized official.
The Regulatory Requirement
Under 21 CFR 312.23(a)(1)(ix), when the person signing an IND 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. This applies to drugs and biologics alike. Your U.S. Agent is the FDA’s domestic point of contact, the person the Agency calls with time-sensitive questions, and the person authorized to act and sign on your behalf.
One caution when comparing providers: most low-cost "FDA agent" services sell only the U.S. agent designation tied to facility registration - for food facilities, medical devices, cosmetics, and drug manufacturing establishments (21 CFR 207.69). Those are different requirements, covering registration and listing of facilities and marketed products, and they do not satisfy the IND countersignature rule. ECD Life Sciences provides the IND-level service.The ECD Life Sciences Advantage
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.
Secure FDA Communications
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.
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
FDA Submission Support
ECD Life 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:
- eCTD publishing and quality review of submission-ready documents
- Electronic submission through the FDA ESG
- Initial IND submission support and ongoing IND maintenance
Coverage and Responsiveness
FDA correspondence does not wait, and neither does ECD Life Sciences. Every FDA communication is acknowledged to your team within one business day. Time-sensitive Agency requests are escalated by phone, and the ECDLS team is briefed on every program, so coverage continues without interruption. All correspondence is handled through Part 11 compliant systems with documentation of every Agency interaction.
Contact Us
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.
Pricing - U.S. FDA Agent
Most firms in this market ask you to call for a quote. We publish our fees. ECD Life Sciences engagements include U.S. Agent designation, Form FDA 1571 countersignature by our principal, and a 24-hour response commitment by a named backup.
A note on price comparisons: You will find "FDA agent" services online for $300 to $860 per year. They are not in any way similar to what ECD Life Sciences offers. Those services cover administrative facility registration - a U.S. agent designation that foreign facilities need to ship FDA-regulated products into the United States: food and dietary supplements, medical devices, cosmetics, and drug manufacturing establishments (21 CFR 207.69). That is registration and listing compliance for facilities and marketed products, and for that purpose those services are fine. The IND countersignature requirement (21 CFR 312.23(a)(1)(ix)) belongs to a different regulatory regime: clinical drug development. The agent named on your Form 1571 is the person the FDA calls about your protocol, your safety data, and your development program - and that is the service offered by ECD Life Sciences.
U.S. Agent of Record + A La Carte Support
$2,500 per month
No setup fees, no routine per-submission charges, & no minimum term
- U.S. Agent designation and countersignature of Form FDA 1571
- Same-business-day triage and escalation of FDA correspondence
- 24-hour response commitment, backed by a named backup on every engagement
- Routine submissions through the FDA Electronic Submissions Gateway
- A direct line to regulatory counsel when an Agency question needs more than forwarding.
U.S. Agent + Retained Regulatory Support
$5,000 per month
Ongoing strategic advice, document preparation, & active IND maintenance.
- Everything listed in the U.S. Agent of Record
- Up to 10 hours per month of senior regulatory work: IND amendments, annual reports, safety reports, and FDA correspondence
- Routine eCTD publishing and ESG submission included
Note: Large regulatory deliverables not included in the monthly support fee (for example, IND build and submission, Orphan drug designation application, etc.); however, retained hours may be credited against fixed-fee project quotes at a rate of $250 per hour.
Contact Us
We are here to help! Provide a few details so we can offer the best solution. Tell us about your program and where it stands with the FDA. We respond to every inquiry within 24 hours. Interested in U.S. FDA Agent Services? Mention your product type and target filing timeline in your
message, so our team can come to the first call prepared.All engagements begin under a CDA / NDA. We are happy to sign yours.
FAQs
Common questions about U.S. FDA Agent services for Sponsors of a U.S. IND
What is a U.S. FDA Agent?
When a company based outside the United States submits an IND, the FDA requires the Sponsor to identify a U.S.-based agent. That agent countersigns the application (Form FDA 1571), serves as the FDA's domestic point of contact, receives Agency communications on your behalf, and is authorized to act for you before the FDA. The requirement is set out in 21 CFR 312.23(a)(1)(ix). This is different from the U.S. agent required for foreign facility registration (21 CFR 207.69), which is an administrative designation for manufacturing establishments, not for drug development.
What does a U.S. FDA Agent do for a foreign Sponsor?
U.S. regulations require any foreign sponsor conducting a clinical trial under an IND to have a U.S. agent. The agent receives FDA communications on the sponsor’s behalf and countersigns Form FDA 1571. ECD Life Sciences serves in this role for international biotech and pharmaceutical companies.
Who actually countersigns our IND?
Daniel Weiss, MD, Principal of ECD Life Sciences, a U.S.-based drug development physician, is named on and countersigns Form FDA 1571. Under 21 CFR 312.23(a)(1)(ix), an individual U.S.-based agent fully satisfies the requirement.How much does it cost?
Pricing is published openly. U.S. FDA Agent services are $2,500 per month. A Full Regulatory Partnership, which adds 10 hours per month of senior regulatory support, is $5,000 per month. Larger projects such as a full IND build are quoted separately.
What happens if our agent is unreachable when the FDA calls?
Every engagement designates a backup who is briefed on your program and authorized to receive and escalate FDA correspondence. You will never depend on one person’s calendar.
Can you publish and submit in eCTD format?
Yes, we publish submission-ready documents in eCTD format and submit through the FDA Electronic Submissions Gateway, including INDs, amendments, annual reports, and safety reports.
ECD Life Sciences is a young firm. What is their track record?
The firm is 3 years young; the experience is not. Our principal built the clinical development organization at Schrödinger as Head of Early Clinical Development, where his teams filed three successful INDs and CTAs in oncology, following senior translational and early clinical roles at Chugai Pharma USA. You are hiring that track record directly, without a large firm’s overhead in price.
Do we need the full service, or just the agent?
If your team has internal regulatory capability and simply needs a U.S. presence, U.S. Agent of Record is enough. If this is your first U.S. IND, or your team is lean, the integrated support usually costs less than assembling the same capability piecemeal. We will tell you honestly which fits after one call.
Does ECD Life Sciences maintain professional liability insurance?
ECD Life Sciences maintains professional liability insurance covering its consulting and U.S. Agent services.
Can ECD Life Sciences author and submit our IND and maintain documents?
Yes. IND authoring and submission - all five modules, eCTD publishing, and transmission through the FDA Electronic Submissions Gateway - is available as a fixed-fee project or within the U.S. Agent + Retained Regulatory Support tier. Ongoing maintenance documents, including DSURs, annual reports, and protocol amendments, are handled the same way.
How does ECD Life Sciences demonstrate it meets the requirements to serve as a U.S. Agent?
The FDA requires the U.S. agent to reside or maintain a place of business in the United States (21 CFR 312.23(a)(1)(ix)). ECD Life Sciences is a U.S.-registered business with a federal EIN and a D-U-N-S number, and it maintains a secure electronic connection with the FDA confirmed by the Agency. Documentation is available on request during diligence.
Can ECD Life Sciences represent us in FDA meetings?
Yes. Pre-IND meeting preparation, briefing documents, and meeting attendance are included in the Retained Regulatory Support tier and are also available as separately scoped engagements. We prepare the briefing package, coordinate with the Agency, and attend with your team.
Drug Development Consulting | Regulatory Publishing & Submissions | U.S. FDA Agent | Clinical Operations Oversight