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  • Home
  • About Us
  • Our Team
  • Services & Expertise
    • Strategy Planning
    • Product Development and Standards
    • Regulatory Submissions
    • Re-scheduling / Re-classification Services
    • Postmarket Compliance & Surveillance
    • Regulatory and Administrative Appeals
    • Literature-Based Medicine Submissions
    • Biosimilar & Biotechnology Medicine Development
    • Due Diligence and Technical Assessment
    • Quality Management Systems
    • Authorised Representation, Sponsorship & Distribution Management
    • Reimbursement – Strategy, Advice and Submissions
    • Distribution Services
    • Diagnostics and IVDs
    • Biocompatibility
  • Blog
  • Events
  • Videos
  • Contact Us

Blog

TGA will require DOC’s to be submitted for Class I ARTG registrations

October 2, 2020 | | Luis Jimenez

Your guide to claiming temporary exemption from TGO91/92 compliance

October 2, 2020 | | Nicole Tan

New Guidance on FDA ISO 10993-1

September 14, 2020 | | James Morrison

Australian Prescription Medicine Pathways – Project Orbis

September 1, 2020 | | Luis Jimenez and Robert Stringer

TGA Advertisement Framework Revisions Hard at Work During Pandemic Times

August 31, 2020 | | Luis Jimenez

Chemical Characterisation – no simple matter

August 28, 2020 | | James Morrison

Multiple Function Devices

August 26, 2020 | | Ruth Black

Impact of COVID-19 on Medical Device Sales and Reimbursement in Australia

August 10, 2020 | | Sarah Griffin

What you need to know about disinfectants in Australia

August 7, 2020 | | Jenny Lin

That’s ODD: can your medicine benefit from incentives for treating rare disorders?

July 31, 2020 | | Vergel Manalo
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Brandwood CKC is the premier regulatory, quality systems and reimbursement consultancy in Australia serving local and international healthscience innovators for more than 20 years.

ABN: 61 128 762 505

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