Technical Documentation|pharmaceutical regulatory science|Unit 3|Sem 8 #technicaldocumentations

Technical Documentation for export of pharmaceutical products: There are various details need to be submitted for export approval to Drug controller office. Topic explained: 1. Technical documentation 2. PAN number 3. Bank Statements 3. Bankar certificate 4. IEC number 5. Indian trade classification of product 6. Proof of ownership of business 7. GMP certification 8. Dossier details For Other videos of Pharmaceutical Regulatory Science, Click on Links…. 1. Stages of Drug Discovery https://youtu.be/tl3Qcai-Llo 2. Drug Development Process https://youtu.be/9k_K0kR-6EY 3. Pre-Clinical Studies https://youtu.be/3AafnX4oySs 4. Non-Clinical Activities https://youtu.be/1NzHA170r6E 5. Clinical Studies https://youtu.be/3yiIWQP5C3o 6. Innovator vs Generic https://youtu.be/rzR27JfcadM 7. Concept of Generic https://youtu.be/2voRMQWxnNs 8. Generic Drug Products Development https://youtu.be/CVa2xzXeBTY 9. Investigational New Drug Application https://youtu.be/kl_e_TTzj08 10. New Drug Application https://youtu.be/nDT6SyRZRg8 11. Abbreviated New drug application https://youtu.be/J_V4iNZBGyM 12. Changes to an Approved NDA or ANDA https://youtu.be/BeHZPKvfmDU 13. Regulatory Authorities of India https://youtu.be/ZRxl7FPNXYc 14. Overview of Regulatory Authorities of United State https://youtu.be/OM9apOjwdhM 15. Overview of Regulatory Authorities of European Union https://youtu.be/ZRJBqqC7Ihs 16. Overview of Regulatory Authorities of Australia https://youtu.be/E4ZNbmap-bw 17. Overview of Regulatory Authorities of JAPAN https://youtu.be/2j8s4xeg8pM 18. Overview of Regulatory Authorities of CANADA https://youtu.be/flG_e4FzRO0 19. Type of Applications https://youtu.be/jGSH6izFOXo 20. Procedure for export of pharmaceuticals https://youtu.be/BZSzB4VgqPo 21. Technical Documentation https://youtu.be/wwXYmXa57a8 22. Drug Master Files https://youtu.be/cIhZhmsdnPc 23. Common Technical Document|CTD| https://youtu.be/a0ztZz5g5V8 24. Electronic common technical document|eCTD https://youtu.be/RKQqo1ksI88 25. ASEAN Common technical dossier https://youtu.be/RBFHc9EzRek 26. Developing of Clinical trail protocols https://youtu.be/wz8Q16YIq2U 27. Institutional Review Board https://youtu.be/sZ3Z2aXPQAk 28. Informed Consent Process and Procedure https://youtu.be/7CH5gFSf0G4 29. GCP Obligations of Investigators https://youtu.be/8zPFf8Jyphs 30. GCP obligations of sponsor https://youtu.be/F7aEjYBEmOQ