Regulatory

Five Corners offers consulting services to achieve your regulatory ambitions. We can provide regulatory strategy development for the Asia Pacific Region and Europe, providing a clear regulatory pathway from concept to commercialisation. This service is provided by in-house experienced Regulatory Specialists who have worked both in industry and consulting across a number of therapeutic disciplines including medical devices, biologics and pharmaceuticals.

For regulatory approval requirements, we undertake the following:

The Australian Therapeutic Goods Administration

  • Preparation and submission of New Client ID Forms
  • Set up of eBusiness Service Access for New Clients
  • Lodgement of initial Manufacturers Evidence Applications and submitting ongoing updates
  • Searching and suggesting GMDN codes relevant to your product
  • Preparation and submission of Medical Device and In Vitro Medical Device Applications
  • Preparation of Level 1 and 2 Application Audit Packs for the Therapeutic Goods Administration
  • Preparation and submission of Full Conformity Assessment Applications for overseas manufacturers where Full Conformity Assessment is required
  • Assisting local Australia manufacturers with Conformity Assessment applications
  • Preparation of Manufacturer's Declaration of Conformity Documents
  • Preparation and submission of Annual Reports for Class IIb Implantable Medical Devices, Class III Medical Devices and AIMDs
  • Maintaining your ARTG entries post inclusion
  • Assisting with accessing unapproved therapeutic goods routes including the TGA’s Special Access Scheme and Authorised Prescriber program
  • Preparation and submission of Clinical Trial Notification Forms
  • Coordinating product recalls, recalls for product correction, and overall management of communications with the TGA's Recalls Unit
  • Submission of Incident Reports and managing communications with the TGA's Post-Market Surveillance Branch (PMSB)

New Zealand's MedSafe

  • Preparation and submission of New Client ID Forms
  • Set up of WAND Access
  • Preparation and submission of Medical Device and Notifications

At Five Corners, our staff has extensive experience in preparation and submission of applications to both agencies through the spectrum from Class I Medical Devices to AIMDs.

Five Corners can also assist with overseas Regulatory strategy and submission. We have expertise in preparation and submission of 510(k) notifications to the United States Food and Drug Administration as well as medical device applications to Health Canada and many Asian markets. This expertise is across many device classifications, particularly devices incorporating animal derived materials.