Regulatory

Drug development is a highly regulated industry, and complying with all the regulations can be a tedious and confusing process. AFG Consulting is here to make the process easier. We provide full regulatory services for over-the-counter (OTC) and complementary medicine that meet both TGA and Medsafe standards. 

How we can help you with regulatory affairs
  • Listing new complementary medicine (AUSTL)
  • Listing new AUSTR (OTC) medicine
  • Listing new medical devices
  • Listing of overseas manufacturers
  • Responding to any TGA requests for information, such as a ‘Section 31’
How we helped AMD with regulatory issues

AFG Consulting is the quality & regulatory representative for Advanced Medical Devices, which manufactures medical face masks from its factory in Sydney.

AFG listed the company’s surgical masks with the TGA. We implemented ISO9001 and succeeded in obtaining a high-standard BSI benchmark certification as well as a CE certificate from an EU authorised body.

Advanced Medical Devices is now Australia’s largest manufacturer of N95 masks and exports to many countries throughout the world.


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Thank you AFG

We have used the services of Frank for a few years now, we find his deep knowledge of the Regulatory environment and Quality Assurance, combined with a practical approach to commercial reality – refreshing and invaluable.
 
As CEO of Complementary Medicines Group I would highly recommend Frank’s services and consider him to be part of my unofficial Board of Advisors.

AFG Consulting Quality & Regulatory

Contact: Frank Galluzzo
Phone 1800 905 021
Email frank@afgconsulting.com.au

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