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)