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
6. Select the options as shown on the screen below. Click on the Next button. Or if youwant to export the certificate with .P7B extension/format or to export .CERextension/format follow the next step.7. Select Cryptographic Message syntax Standard – PKCS #7 Certificates (.P7B),check R Include all certificate in the certification path if possible.8. Select DER encoded binary X.509 (.CER) and click on the Next button.
9. Give a file name and select the location where you want to save the file. Click on theNext button. Then click on Finish.You public key is ready. This is the key that you should use when registering.To export private key (.PFX or .P12)1. Select the certificate and click on Export, Click on next on the next screen2. Select Yes, export the private key and click on the Next button.
- 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 and 24: Confirm that the correct version of
- Page 25 and 26: 7. Select the Send document menu it
- 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: 3. Click on the Export button to cr
- 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
- Page 75 and 76: Figure 3: File System Settings, Dir
- Page 77 and 78: 6. Click on the Save changes button
- Page 79 and 80: Figure 7: Submission Types Supporte
9. Give a file name and select the location where you want to save the file. Click on theNext button. Then click on Finish.You public key is ready. This is the key that you should use when registering.To export private key (.PFX or .P12)1. Select the certificate and click on Export, Click on next on the next screen2. Select Yes, export the private key and click on the Next button.