Turnkey Regulatory Consultation
Region-Specific Regulatory Support
Food Product Registration
Formula Review
Ingredients Assessment
Translation Services
Novel Food Registration
Get professional assistance to meet regulatory compliance, solve validation issues, acquire TGA certification, register food products, review claims and much more.
The Therapeutic Goods Administration (TGA) is the body of the Australian Government Department of Health. It regulates complementary medicines (AUST-L), which include vitamins, herbs, nutritional supplements and natural health supplements. The agency is also responsible for regulating goods, such as prescription medicines, sunscreens, vaccines, medical devices.
Any organization engaged in manufacturing, supplying, distributing, importing or exporting these products must acquire TGA certification. Quality Smart Solutions employ several ex-TGA inspectors as consultants to provide the best and most reliable TGA compliance solutions.
We will assist you in food classification, label and claims review, novel food registration, ingredient analysis and preparing complementary medicine applications. If you want to enter the Australian market, we will help you obtain a TGA manufacturing certificate before listing or registering your device or drug on the Australian Register of Therapeutic Goods (ARTG). We will also help you with end to end solutions, including dossier review, drug development, general advice and registration and application submission support.
Get help from former TGA inspectors who will help you in Regulatory Advice for Complementary Medicines, Product Listing on ARTG or Product’s Recipient Change Post the Listing, Review or Preparation of Nutrition Information Requirements.
Our services include setting out product strategy, review of your products and their classification, determining in which set of TGA Regulations your products fall to meet the requirements.
Get proper Compliance Consulting from TGA former experts. We will assess all your compliance aspects and enable you to adhere to the food compliance requirements set by the Therapeutic Goods Administration.
Leveraging technology, we provide assistance to meet regulatory compliance and enter the Australian market without any worry of compliance issues. With us, you’re able to meet any changes in TGA regulations.
Get guidance about TGA regulations, prescription medicines, biotech medicines, generic medicines, dossier to meet TGA regulations and acquire certification to enter the Australian marketplace without any compliance issue.
You will get assisted by a team of qualified TGA compliance experts who will carry out audits and inspection of your product materials, labelling, packaging and more to ascertain that you are adhering to TGA Regulations.
Get assistance and efficiently process documentation, prepare and augment application to get TGA Certificate. Our support is available for domestic and foreign clients to register their products and enter the Australian market.
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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.