DAVID WILKINSON
Consultant
REGULATORY
RESULTS
Complementary Medicines I Foods I Medical Devices I Cosmetics & Personal Care
Regulatory Results is a regulatory affairs consultancy with your goals foremost in mind. I aim to 'cut the jargon' and deliver meaningful results for your business: guiding you through the process if you choose, or simply getting the job done. I partner with you to efficiently get your product to market and then provide ongoing support throughout its lifecycle.
Director David Wilkinson holds degrees in Pharmacy and Pharmacology, and with almost two decades of consulting experience brings to Regulatory Results both the scientific know-how and the regulatory understanding to provide innovative solutions that truly fit your needs.
In an ever-changing regulatory environment, sometimes what you need is a fresh approach.
AbouT
HOW I
cAN HELP YOU
your product as a medicine
Marketing a product as a medicine in Australia may be more accessible than you think. This strategy can offer distinct advantages over selling a product as a food or a cosmetic, as it enables you to legally advertise 'therapeutic claims': distinguishing your product in a crowded marketplace. Regulatory Results can prepare a feasibility report for your proposed product as a medicine: providing you with a summary of the steps to market and the knowledge and options you need to move forward.
advertising
Whichever path to market you choose for your products, advertising is crucial for commercial success. Regulatory Results can review your draft or finished therapeutic goods advertising: whether for print media, digital, radio or television broadcast - alerting you to any potential issues in relation to the Therapeutic Goods Advertising Code (TGAC). Conversely, advertisements for cosmetics or foods don't need to comply with the TGAC, but statements that could be taken as therapeutic claims are best avoided - I can provide guidance on this also.
the therapeutic interface
The classification overlap between foods or cosmetics and that of therapeutic goods can be complex to navigate. Regulatory Results has an extensive understanding of these issues and can provide you with tailored advice regarding your product and the 'therapeutic interface': empowering your business to choose the most suitable path to market.
ONGOING SUPPORT
As a product moves through its lifecycle your needs and strategies may change. It may be advice regarding new therapeutic claims for an existing medicine to give your product a fresh edge in the marketplace, through to guidance on a new slant for an advertising campaign: Regulatory Results provides ongoing support, partnering with your business through these changes.