USA: +1 617 939 9497 | UK: +44 2039 962936 | EU: +34 607 939 266
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Clinical Trial Regulatory Submissions to the TGA in Australia

Sofpromed provides regulatory submission services for clinical trials to be conducted in Australia, including:
  • Creation and review of documents required for regulatory submission (protocol, Investigator’s Brochure, drug labels, etc.)
  • Adaptation and translation of documents according to local requirements
  • Preparation and review of submission package
  • Completion of clinical trial application form
  • Clinical trial application submission to the Therapeutic Goods Administration (TGA)
  • Responses to clarification requests and questions raised by the TGA
  • Phase I-IV clinical trials with drugs or medical devices in all therapeutic areas (oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious and respiratory diseases, among others)
Please contact us if you need clinical trial regulatory submission services in Australia.
Contact us to request more information or get a quote

US: +1 617 939 9497

 UK: +44 2039 962936

EU: +34 607 939 266