Clare Martin & Associates Pty Ltd was established as a regulatory consultancy in 1997. The Company provides regulatory and compliance consulting services to Australian and international businesses operating in the medical devices, OTC and listed medicines, cosmetic & personal care products categories.

The regulatory requirements for these sectors are complex. Ensuring that your business and products comply with the regulatory requirements of government agencies such as The Therapeutic Goods Administration (TGA), National Industrial Chemicals Notification and Assessment( NICNAS), and the Australian Quarantine and Inspection Service (AQIS) can be challenging.

This is where an experienced regulatory consultant can provide a value added service to your business.

Understanding the constraints of operating in a regulated marketplace can be the difference between product success and failure.

Is my product a therapeutic good in Australia?

The ingredients in a product, the claims made, and how a product is presented can all contribute to determining if your product is regulated as a therapeutic good.

Understanding how the regulatory controls impact on your product is critical to be able to position your product appropriately.

Products that sit on or near the boundary between medicines, medical devices, cosmetics or foods can be challenging for businesses to determine how to proceed. Knowledge of the regulatory requirements is critical to determine which is the correct pathway for your product.

Consultant Profile

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Clare Martin has over 30 years experience in the therapeutic goods industry. Clare is qualified in Pharmacology (USyd) and Marketing (UNSW) and has a unique skill set, developed from working in the disciplines of Clinical Research, Marketing, Industry Association Management, Regulatory Affairs and Consulting.

Prior to founding Clare Martin & Associates, Clare was responsible for the establishment and management of the therapeutic goods advertising approval system at ASMI (formerly Proprietary Medicines Association of Australia - PMAA) as the delegate of the Secretary of the Department of Health & Ageing.

 Clare was a long standing member of the Government statutory committee, the Therapeutic Goods Advertising Code Council, which is responsible for management and review of the Therapeutic Goods Advertising Code.

She has also been a member of TGA Working Party’s on oral hygiene products, anti-bacterial products, and the TGA's OTC Medicines Business Process Reform Project.

Clare is an active member of Industry Associations representing the interests of companies supplying personal care, cosmetics & toiletries (ACCORD), dental products (ADIA), and direct selling companies in the therapeutics, cosmetics & personal care categories  (DSAA).

Clare is a member the Regulatory Affairs Committees for the Industry Associations, ACCORD and ADIA. In her role as Deputy Chair of the ADIA Dental Regulation Committee, Clare represents the interests of the Dental Industry at the quarterly TGA key stakeholder forum -TGA’s Regulatory & Technical Forum.