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Regulatory Compliance, Strategy & Submissions

From the preparation, submission and management of registration applications through to approval, regulatory problem-solving and administrative appeals, Brandwood CKC aims to be an integral part of your team and will work with you every step of the way.

To support you in preparing complete Technical Files and regulatory dossiers, we provide specialist services that include:

  • risk assessments
  • Literature-Based Submissions
  • medical writing capabilities for medicine Module 2 overviews and summaries.

We also offer in-house eCTD and NeeS publishing services.

At A Glance:

  • Medicines

  • Devices

  • IVDs

  • Australian TGA

  • NZ Medsafe

  • CE-marking

  • US FDA 510(k), de Novo and PMA

  • China NMPA

  • ASEAN

  • India

  • Canada

  • Japan

  • Taiwan

  • Korea

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