Regulatory Compliance, Strategy & Submissions

From registration application preparation, submission and management 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.

We support you to prepare complete Technical Files and regulatory dossiers. We specialise in risk assessments, Literature-Based Submissions, and medical writing capabilities for medicine Module 2 overviews and summaries.

We 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

Let Us Know What You Think

If you've got any questions or would just like to learn more about what how we could work together, then get in touch.

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