FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
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10.07.2015
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- Page 1 and 2: FDA Electronic Submissions Gateway
- Page 3: Appendix C. Digital Certificates...
- Page 6 and 7: Figure 1: Overview of the Registrat
- Page 8 and 9: 2.6 Send Submissions to the Product
- Page 10 and 11: eCTD - Electronic Common Technical
- Page 12 and 13: FDAPreparation of multi-filesubmiss
- Page 14 and 15: 3.7 Help and InformationThere are r
- Page 16 and 17: 4. Click the Next button.The Pick a
- Page 18: 8. Click the Next button.The Locate
- Page 21 and 22: 14. Enter a new login User ID and P
- Page 23: Confirm that the correct version of
- Page 27 and 28: - Load tests ensure that you are ab
- Page 29 and 30: 20. To access the receipt, click on
- Page 31 and 32: 4.4 Apply for a Production System A
- Page 33 and 34: submissions (> 7.5 GB), this can ta
- Page 35 and 36: When a Center receives a submission
- Page 37 and 38: The following information is requir
- Page 39 and 40: Be sure to indicate on the applicat
- Page 41 and 42: - Create a local environment that s
- Page 43 and 44: ___________________________________
- Page 45 and 46: Upon receiving the file, signature
- Page 47 and 48: or by obtaining a certificate from
- Page 49 and 50: 3. Click on the Export button to cr
- Page 51 and 52: 9. Give a file name and select the
- Page 53 and 54: 4. Create a password for your priva
- Page 55 and 56: 2. Select "Windows" from the platfo
- Page 57 and 58: 2. Click on the link under Required
- Page 59 and 60: 4. With the box unchecked, a warnin
- Page 61 and 62: . From the Add or Remove Programs d
- Page 63 and 64: Appendix E. Glossary of TermsTable
- Page 65 and 66: Appendix F. AcronymsA list of acron
- Page 67 and 68: Table G-1: Allowable Center Attribu
- Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
- Page 71 and 72: EDIFACT UNB Header InformationDescr
- Page 73 and 74: Consult with an FDA Center represen
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