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Home > approval

Tag Archives: approval

Provisionally yours

Provisionally yours

27th January 2021

Formulated ingredients and premixes: Keeping the IP of a PI

Formulated ingredients and premixes: Keeping the IP of a PI

24th November 2020

Your guide to claiming temporary exemption from TGO91/92 compliance

Your guide to claiming temporary exemption from TGO91/92 compliance

2nd October 2020

Australian Prescription Medicine Pathways – Project Orbis

Australian Prescription Medicine Pathways – Project Orbis

1st September 2020
Recent Blogs
  • Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
    2nd June 2022
  • Medical device software brings new complications around compliance
    30th May 2022
  • Is quality documentation an asset or a burden in regulatory affairs?
    6th April 2022
  • Navigating the impact of the IVDR on marketed products
    24th March 2022
  • Minimizing risk during the transport of medicinal products
    21st March 2022
  • Next Steps for EUDAMED implementation within MDR
    7th March 2022
Recent News
  • Why collaboration and an Integrated Product Development program are key to successful drug development
    14th June 2022
  • Key Takeaways from the PDA Europe Annex 1 Workshop
    7th June 2022
  • Addressing Limitations of Sterility Testing
    9th May 2022
  • Are virtual audits sustainable post-pandemic?
    6th May 2022
  • Orphan Drug Designation: Securing the Significant Benefits
    28th March 2022
  • PharmaLex expands pricing & reimbursement and health economics platform with EBMA Consulting merger
    9th March 2022
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