Pharmaceutical Regulatory Submissions

PharmOut offers consulting services for companies wishing to register pharmaceutical, complementary medicine or dietary supplements with the Australian TGA, for sale within Australia.

Drug Registration

PharmOut can perform the following tasks:

• Reviewing chemistry/pharmacy, preclinical and clinical texts
• Preparing regulatory submissions
• Preparing marketing authorisation applications
• Submitting dossiers and paying fees on your behalf

Our regulatory affairs consultants can assure validation of the dossier, receive questions from the TGA, and prepare suitable responses on your behalf.Our consultants can also co-ordinate the submission of responses and provide expert reports/overviews. 

More information

If you would like a quote or would like to ask questions, please contact us.