Review

• Regulatory requirements for the New Drug approval process in different Countries

  Sangavi C.

  Pages 1-16

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.574
• Regulatory Submission for Drug Approval in North East Asian countries: Hong Kong, South Korea and Taiwan

  Juhi Padh, Ankita Patel, Vinit Movaliya, Khushboo Vaghela, Niranjan Kalanki, Maitreyi Zaveri

  Pages 17-29

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.575
• Recent Regulatory Scenario of Nitrosamines Impurities in Regulated Market US, Europe and Canada

  Richa Trivedi, Ankit Trivedi, Vinit Movaliya, Khushboo Vaghela, Niranjan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri

  Pages 30-36

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.581
• A comparative study on regulatory requirement of parenteral dosage form for various regulated countries

  Vishva Acharya, Ankit Trivedi, Vinit Movaliya, Khushboo Vaghela, Niranjan Kanaki, Maitreyi Zaveri

  Pages 37-49

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.589
• Drug Master File- A Review

  Suraj Kause, Pradnya Raut

  Pages 50-53

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.592
• Implementing Root Cause analysis in Pharmaceutical manufacturing

  Maariyah Tahseen, Maleeha Masood, Trapti Saxena, Prasanthi Domaraju

  Pages 54-57

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.593
• Drugs Manufacturing License Allocation (DMLA): An Effective Tool for e-Governance in fields of Drugs Manufacturing Regulation

  Zuki Patel, Shrikalp Deshpande, Hemant Koshia, Purva Patel

  Pages 58-63

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.595
• Review on Inspectional Observation and Warning Letters

  Disha P Patel, Niranjan Kanaki, Vinit Movaliya, Maitreyi Zaveri

  Pages 64-67

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.597
• Comparative Study of regulatory requirement for preparation of Dossier for Registration of Oral Solid Dosage form in Zimbabwe and Myanmar

  Pankaj Nerkar, Atul Patil, Gaurav Shaha, Vikrant Deshmukh

  Pages 68-74

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.602
• Regulatory requirements for Medical Device Registration in Kingdom of Saudi Arabia, US and European Union

  Rajveer Bhaskar, Monika Ola, Subhash Singh Saharan, Vishal Nikam

  Pages 75-85

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.605
• Orphan Drugs Overview and Regulatory review procedure

  Varshith Kumar Gubyal, Prakash S Goudanavar, Suhana Elangoli, Akshay Saj

  Pages 86-93

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.609
• Regulatory requirement for Pre & Post-approval management of Generic Drugs in US

  Rajveer Bhaskar, Monika Ola, Bhupesh Patil

  Pages 94-109

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v11i2.611