Expertise

Regulatory Results specialises in complementary medicines and operates across a number of areas, some common examples are outlined below. Of course, I can't include everything here so please don't hesitate to contact me to discuss other ways I can fulfil your needs.

Complementary medicines

feasibility reports for your proposed products - providing you with the knowledge and options to move forward

preparation, submission and maintenance of AUST L (Listed) medicine applications to the Therapeutic Goods Administration (TGA)

review of proposed ingredients regarding suitability for use in medicines marketed in Australia, we can also prepare and submit TGA proprietary ingredient applications

preparation and review of medicine labelling and packaging, ensuring these meet the strict TGA requirements

reviews of medicine advertising to assess compliance with covering legislation - ensuring you're covered

in the case of complaints or disputes with the TGA we can prepare a proactive and timely response - helping you progress toward resolution

Complementary medicines

· feasibility reports for your proposed products - providing you with the knowledge and options to move forward.

· preparation, submission and maintenance of AUST L (Listed) medicine applications to the Therapeutic Goods Administration (TGA).

· review of proposed ingredients regarding suitability for use in medicines marketed in Australia, I can also prepare and submit TGA proprietary ingredient applications.

· preparation and review of medicine labelling and packaging, ensuring these meet the strict TGA requirements.

· reviews of medicine advertising to assess compliance with covering legislation - ensuring you're covered.

· in the case of complaints or disputes with the TGA we can prepare a proactive and timely response - helping you progress toward resolution.

FOODs

· feasibility reports for your proposed product, "food or medicine?" - we can help clarify distinctions between the two categories and provide you with options to move forward.

· assessment of ingredients and permitted quantity limits for different categories of food product in Australia.

· preparation and review of food packaging, including ingredient lists and Nutrition Information Panels.

cosmetics & Personal care

· review of your proposed cosmetic formulation including all ingredients, and assistance with importation and other issues involving the Australian Industrial Chemicals Introduction Scheme (AICIS).

· packaging reviews and advice: guidance to help you understand what can be included.

· reviews of cosmetic advertising, keeping you covered regarding potential therapeutic claims and other issues involving related legislation.

MEDICAL DEVICES

· feasibility reports for your proposed products - providing you with the knowledge and options to move forward.

· preparation, submission and maintenance of medical device applications to the TGA.

· preparation and review of medical device labelling and packaging, ensuring these meet the strict TGA requirements.

· reviews of advertising for medical devices to assess compliance with covering legislation - ensuring you're covered.

· in the case of complaints of disputes with the TGA we can prepare a proactive and timely response - helping you progress toward resolution.

Your EXPERT

David Wilkinson
MPharmacy(UoN), BSc(Pharmacology)(Syd)

I have a long-standing interest in therapeutic products and their regulation and hold a Master of Pharmacy from Newcastle University and a BSc(Pharmacology) from Sydney University.

In a career spanning almost two decades: I got my start with Australia’s premier complementary medicines consulting firm; worked as regulatory affairs manager in a role covering 22 countries; gained a TGA GMP licence and worked as QA Manager; was a compounding pharmacist; specialised in ingredients and created many new products for Australia’s leading brand companies; and spent a number of years as technical manager for Australia’s leading complementary medicines brand. For most of this time I’ve also worked as an independent consultant, distilling these varied experiences into strategic advice for brand companies.

Full CV available on request.