Company Profile

Vick Partridge Is A Highly Experienced Australian Based Regulatory Affairs Consultant Representing Manufacturers That Import And Export Therapeutic Goods To The Australiannew Zealandeuropeanasian And United States Markets Since Starting Vicki Partridge Pty Ltd In 2012Vicki Has Built Up And Extensive Client List In Australiathe United Stateseurope And Asiaincluding Three Companies Capitalised At Over $Us 1 Billionvicki S Particular Specialisation Is In Biological Productshaving Recently Completed Submission Of The First Major Biological Product Dossier To The Therapeutic Goods Administrationtgaof Australiathis Submission Is Very Close To Gaining Approval From The Tgawhich Will Allow A Major Us Company To Market Ten Individual Biological Products Throughout Australiaasia And Europe Vicki Is Able To Provide Both A Unique Consulting Service And Representation As An Agent Or Sponsorand Can Enhance The Existing Knowledge Base Of Internal Regulatory Affairs Staffwhile Streamlining The Path Of Your Medical Devices To Market Through Aecregistration Of Your Company As A Potential Supplier Of Medical Devices To The Australian Market Aecsponsoring Clinical Trials Aecco Ordinating Pre Submission Discussions With The Tga Aecpreparing Submissions For Sas And Prosthesis List Aecsponsor Transfer Of Existing Inclusions Aecassessing Manufacturer S Certification As Issued By European Union Notified Bodies Aecpreparing Responses To Tga Questionsaecpreparingdocumentation To Demonstrate Compliance With Essential Principles Aecpreparing Applications And Assisting With The Device Classification And Gmdn Code Determination Aecconducting Supplier Audits Aecreviewing Advertising Or Promotional Material To Ensure Compliance With The Advertising Code Aecpreparing And Lodging Documentation For Ce Markingand Aecproviding Customised Regulatory Training On Site