ECD Life Sciences
Drug Development Partner and
U.S. FDA Agent for International Sponsors
About
ECD Life Sciences is a drug development partner for emerging biotechnology companies and foreign sponsors entering the United States. We set the development and regulatory strategy, and we do the work: IND authoring and filing, pre-IND meeting preparation, protocol and investigator's brochure development, CRO oversight, and safety reporting. For foreign sponsors, our services include acting as U.S. agent before the FDA, one of several ways we support entry into the U.S. market.
Services
Program Strategy | Regulatory Affairs | Clinical Sciences | Clinical Operations | Clinical Pharmacology | Pharmacovigilance
U.S. FDA Agent Services
Expertise
ECD Life Sciences is run by business partners Daniel Weiss, MD, and Richa Luthra. Dan has more than 25 years of experience in early clinical development, with expertise in IND strategy and authoring, pre-IND meeting preparation, first-in-human study design, and U.S. FDA agent services for international sponsors. Richa has more than 20 years of experience across program and portfolio leadership, spanning clinical, regulatory, CMC, operations, and launch strategy. Clients work directly with the ECD Life Science partners from the first conversation through execution.
Contact ECD Life Sciences
We're 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.
Drug Development Consulting | Regulatory Publishing & Submissions | U.S. FDA Agent | Clinical Operations Oversight