International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  Regulatory requirements for the new drug approval process in different countries

  • Author: C. Sangavi
  • DOI: 10.22270/ijdra.v11i2.574

• Regulatory submission for drug approval in North East Asian countries: Hong Kong, South Korea and Taiwan

  • Author: Juhi Padh, Ankita Patel, Vinit Movaliya, Khushboo Vaghela, Niranjan Kalanki, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v11i2.575

• Recent regulatory scenario of nitrosamines impurities in regulated market US, Europe and Canada

  • Author: Richa Trivedi, Ankit Trivedi, Vinit Movaliya, Khushboo Vaghela, Niranjan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v11i2.581

• A comparative study on regulatory requirement of parenteral dosage form for various regulated countries

  • Author: Vishva Acharya, Ankit Trivedi, Vinit Movaliy, Khushboo Vaghela, Niranjan Kanaki, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v11i2.589

• Drug master file- A review

  • Author: Suraj Kause, Pradnya Raut
  • DOI: 10.22270/ijdra.v11i2.592

• Implementing root cause analysis in pharmaceutical manufacturing

  • Author: Maariyah Tahseen, Maleeha Masood, Trapti Saxena, Prasanthi Domaraju
  • DOI: 10.22270/ijdra.v11i2.593

• Drugs manufacturing license allocation (DMLA): An effective tool for e-governance in fields of drugs manufacturing regulation

  • Author: Zuki Patel, Shrikalp Deshpande, Hemant Koshia, Purva Patel
  • DOI: 10.22270/ijdra.v11i2.595

• Review on inspectional observation and warning letters

  • Author: Disha P Patel, Niranjan Kanaki, Vinit Movaliya, Maitreyi Zaveri
  • 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

  • Author: Pankaj Nerkar, Atul Patil, Gaurav Shaha, Vikrant Deshmukh
  • DOI: 10.22270/ijdra.v11i2.602

• Regulatory requirements for Medical Device Registration in Kingdom of Saudi Arabia, US and European Union

  • Author: Rajveer Bhaskar, Monika Ola, Subhash Singh Saharan, Vishal Nikam
  • DOI: 10.22270/ijdra.v11i2.605

• Orphan drugs overview and regulatory review procedure

  • Author: Varshith Kumar Gubyal, Prakash S Goudanavar, Suhana Elangoli, Akshay Saj
  • DOI: 10.22270/ijdra.v11i2.609

• Regulatory requirement for pre & post-approval management of generic drugs in US

  • Author: Rajveer Bhaskar, Monika Ola, Bhupesh Patil
  • DOI: 10.22270/ijdra.v11i2.611