Steps for CROs, U.S. Agents, and Consultants to Create an ESG NextGen Account
Steps for CROs, U.S. Agents, and Consultants to Create an ESG NextGen Account
1. Register for an ESG NextGen Account under your Company:
- CROs, U.S. Agents, and Consultants will register for a single account with their company within ESG NextGen Unified Submission Portal (USP) and will be able to submit for each client under this account.
2. Submit a Letter of Non-Repudiation:
- Submit a Letter of Non-Repudiation: A company-wide Non-Repudiation Letter will cover all employees within the company and can be uploaded within the USP. An Individual Non-Repudiation Letter will only cover the individual listed within the letter and that individual will have to upload or generate the Non-Repudiation Letter covering them during registration within the USP.
3. Submit a Letter of Authorization:
- Ensure your company obtains and submits a Letter of Authorization (LOA) to the FDA for each client. This letter should clearly authorize your submissions on the client’s behalf and include both your company’s name and the client’s name. Letters of Authorization can be uploaded within the USP.
FAQs for CROs and Consultants
1. Can I submit for multiple clients under one account?
- Yes, CROs, U.S. Agents, and Consultants will be able to upload for the companies represented by the Authorization Letters uploaded.
2. What happens to my old WebTrader accounts?
- All WebTrader accounts will be retired once ESG NextGen goes live. Information from WebTrader accounts will be migrated over to ESG NextGen.
3. Who do I contact for assistance?
- For support with registration, account management, or submission processes, reach out to the ESG NextGen Support at ESGNGSupport@fda.hhs.gov.