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U.S. Department of Health and Human Services

For Industry

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Steps for CROs, U.S. Agents and Consultants to obtain ESG accounts

If you are a CRO, U.S. Agent or Consultant please use the following steps to create ESG accounts:

  1. You will have to register for separate account(s) for each of your clients. Make sure both your company name and your client company name are used in the account name e.g. Consultant compamy1 for client1.

  2. Your client must submit an authorization to FDA. Please make sure the authorization lists your company name in the letter authorization.  
  3. Your company must submit a letter of Non-Repudiation to FDA.