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          Pharmaceutical

        1. Advanced course in GLOBAL REGULATORY AFFAIRS [GRA-API, Formulations, Medical Devices, Biosimilars, OTC]
        2. REGULATORY AFFAIRS-Formulation
        3. REGULATORY AFFAIRS-API[DMF/ASMF/CEP]
        4. QA-QM [ Quality Assurance and Quality Management]
        5. Regulatory Submissions as per CTD-eCTD, ACTD , NeeS
        6. Advanced course in Clinical Research[CR]
        7. Advanced course in Documentation [PD]
        8. Advanced course in Pharmacovigilance [PV]
        9. Advanced course in Patents Laws and Procedures [IPR]
        10. Advanced course in Pharmaceutical Management[PM]
        11. Advanced course in Medical Writing [MW]
        12. Stability Testing in Pharmaceuticals
        13. Effective CMC Writing and Review Skills
        14. Nutraceuticals

        15. Advanced course in NUTRACEUTICALS[NUTRA]
        16. Medical Device

        17. GLOBAL Medical Devices Regulations i.e. MDR course[India, Europe, USA, ASEAN, ROW markets]
        18. Medical Device-Quality Assurance
        19. Internal Auditor/Lead Auditor QMS 13485-2016, ISO 19011-2018 Course
        20. Medical Device -Indian Regulation, Bis Submission, Sugam Portal Submission
        21. Medical Device-European MDR, CE Mark
        22. Medical Device- USFDA Submission
        23. MDD to MDR Implementation
        24. Medical Device-Risk Management
        25. Implementation of MDSAP, An Overview

      Raajpharma eLearning Short Courses

          Medical Device

        1. Biologics/Biosimilar Submission as per US and EU
        2. Medical Device labeling as per EU and ISO 15223
        3. Pharmaceutical Product labeling as US, EU and India
        4. Computer System Validation, 21 CFR part 11, GAMP 5
        5. Internal Auditor/Lead Auditor QMS 13485-2016, ISO 19011-2018 Course
        6. Medical Device -Indian Regulation, BIS Submission, Sugam Portal Submission
        7. Medical Device-European MDR, CE Mark
        8. Medical Device- USFDA Submission
        9. MDD to MDR Implementation
        10. Medical Device-Risk Management
        11. Medical Device Design and Development
        12. Pharmaceutical

        13. Effective CMC Writing and Review Skills
        14. Drug Regulation In US
        15. Drug Regulation in Europe
        16. Drug Regulation in ROW
        17. Drug Substance Regulation-Drug Master File
        18. Formulation Development
        19. Drug Development Process
        20. Good Manufacturing Practice
        21. Regulatory System in Canada
        22. ICH Q 1-Stability Studies
        23. ICH Q2-Analytical Validation
        24. ICH Q3-Impurities
        25. ICH Q 6-Specification
        26. ICH Q9- Quality Risk Management
        27. ICH Q10- Pharmaceutical Quality Management
        28. Importance of Data Integrity in Pharmaceuticals
        29. Nutraceuticals

        30. Regulatory Perspective of Nutraceuticals
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Raaj Global Pharma Regulatory Affairs Consultants (RAAJ GPRAC)

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