Vicki Partridge Pty Ltd

Vick Partridge is a highly experienced Australian-based Regulatory Affairs Consultant representing manufacturers that import and export Therapeutic Goods to the Australian, New Zealand, European, Asian and United States markets. Since starting Vicki Partridge Pty Ltd in 2012, Vicki has built up and extensive client list in Australia, the United States, Europe and Asia, including three companies capitalised at over $US 1 billion. Vicki's particular specialisation is in Biological products, having recently completed submission of the first major Biological Product Dossier to the Therapeutic Goods Administration (TGA) of Australia. This submission is very close to gaining approval from the TGA, which will allow a major US company to market ten individual Biological products throughout Australia, Asia and Europe. Vicki is able to provide both a unique consulting service and representation as an Agent or Sponsor, and can enhance the existing knowledge base of internal regulatory affairs staff, while streamlining the path of your medical devices to market through: • registration of your company as a potential supplier of medical devices to the Australian market;• sponsoring clinical trials;• co-ordinating pre-submission discussions with the TGA;• preparing submissions for SAS and Prosthesis List;• sponsor transfer of existing inclusions;• assessing Manufacturer's Certification as issued by European Union Notified Bodies;• preparing responses to TGA questions;;• preparing documentation to demonstrate compliance with Essential Principles;• preparing applications and assisting with the device classification and GMDN code determination;• conducting supplier audits;• reviewing advertising or promotional material to ensure compliance with the Advertising Code;• preparing and lodging documentation for CE marking; and • providing customised regulatory training on-site.
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Employee Count: 1
Keywords: hospital & health care