• BioPharma – Asia/Europe/USA Regulatory Updates, Jan 2023

    9 January 2023 Pharma Regulatory Updates
    ASIA | EUROPE | USA ASIA Guide for ADR reporters ...
  • Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Dec 2022

    9 January 2023 Pharma Regulatory Updates
    USA (FDA) | EUROPE (EU) | UNITED KINGDOM (MHRA) | IRELAND (HPRA) | CANADA (HC) |INDIA ...
  • BioPharma – Asia/Europe/USA Regulatory Updates, Dec 2022

    15 December 2022 Pharma Regulatory Updates
    Asia | EUROPE | USA Asia Applying for the import of unregistered medicines ...
  • New Guidance: ANDA Pre-Submission Facility Correspondence

    14 December 2022 Pharma Regulatory Updates
    The Food and Drug Administration (FDA) is issuing this revised draft guidance to incorporate ...
  • BioPharma – USA/Europe Regulatory Updates, Week 2 Nov 2022

    23 November 2022 Pharma Regulatory Updates
    Europe (EU) | USA Europe (EU) EMA consults on planned update to computerized ...
  • BioPharma – USA/Europe/Asia Regulatory Updates, Week 1 Nov 2022

    11 November 2022 Pharma Regulatory Updates
    Europe (EU) | USA | Asia Europe (EU) MHRA updates biosimilar guidance to allow ...