PHARMACEUTICALS LISTING/REGISTRATION:

In ArKi Labs, we focused on assisting industry in achieving their goals. Do you need assistance in listing/registration of your product with TGA? In Arki Labs we can provide advice and assistance on listing/registration of the following products:

  • Complementary Medicines
  • Over the counter medicines (OTC)
  • Prescription medicines
  • Sunscreens
  • Cosmetics

IN ARKI LABS WE PROVIDE SERVICES INCLUDING:

  • Prepare listing applications for complimentary medicine, over the counter (OTC) medicines, sunscreens and other listable products
  • Prepare Common Technical Document (CTD) related to chemistry and toxicology
  • Prepare and submit chemistry, efficacy and toxicity data
  • Literature-based submissions
  • Provide advice on product labeling and product claims
  • Preparation of Consumer Medicine Information leaflets, label compliance and claims advice
  • Conduct appropriate testing as part of product listing/registration process required by TGA
  • Analytical method development and validation support