International Journal of Drug Regulatory Affairs (IJDRA)

Table of Contents

• REVIEW ARTICLE

  Regulatory aspects for Biologic Product licensing in Australia

  • Author: Sanjeev Kumar Maurya, Vikesh Kumar Shukla, Sunny Kumar Maurya, Prachi Kaushik, Indu Maurya
  • DOI: 10.22270/ijdra.v7i2.310

• Understanding the globally harmonized system of classification and Labeling of Chemicals-The Purple Book

  • Author: Subba Rao Bayya
  • DOI: 10.22270/ijdra.v7i2.312

• A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India

  • Author: Anshul Bansal, Vikesh Kumar Shukla, Shikha Chauhan
  • DOI: 10.22270/ijdra.v7i2.313

• Simultaneous estimation of xanthine alkaloids (Theophylline, Theobromine and Caffeine) by High-Performance Liquid Chromatography

  • Author: Shruti Mourya, Ramesh Bodla, Ravikant Taurean, Akanksha Sharma
  • DOI: 10.22270/ijdra.v7i2.315

• Pre-filled syringes in developed and developing region: An insight into Regulatory considerations

  • Author: Anjali Kapoor, Geeta Aggarwal
  • DOI: 10.22270/ijdra.v7i2.317

• Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format

  • Author: Shrikant Godiyal
  • DOI: 10.22270/ijdra.v7i2.318

• Overview of current Regulations governing Medical Devices

  • Author: Bobby George
  • DOI: 10.22270/ijdra.v7i2.321