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.

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 recommending GMDN codes relevant to your product
• Preparation and submission of Medical Device and In Vitro Medical Device Applications
• Preparation of Level 1 and 2 Audit Packs for the Therapeutic Goods Administration
• Preparation and submission of Full 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
• Preparation and submission of Special Access Scheme Forms
• Preparation and submission of Clinical Trial Notification Forms

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.