Roy Hardman



Roy Hardman Bsc, MAppSc, M Well, PhD (candidate) is the Managing Director of Right Time Business PTY a company that has specialised in the inclusion of devices on to the Australian Register of Therapeutic Goods (TGA) including the requirements for disinfectants. In addition to conducting conformity assessments and clinical trial requirements for Medical Devices in Australia with the TGA. This is a specialist company that focuses on Medical Devices in both the Medical and Dental Industry and has been involved with the TGA on working committees and industry representation since the 2001 when the new legislation was introduced.

Roy has over 34 years of extensive experience within the Medical and Dental Markets in Australia, New Zealand and around the world. Roy  currently works with over  180 different sponsors and manufacturers in Australia and worldwide, with clients in : Germany, Lichtenstein, Italy, New Zealand, Israel, China, Switzerland, Japan, France, United Kingdom, Ireland, South Korea, Belgium, Singapore, Brazil, United States of America, Malaysia, India, Pakistan, and Spain.

He has a comprehensive experience with the harmonisation of regulatory requirements in EU and Australia and New Zealand. Also worked representing clients with regulatory requirements with the FDA in the United States.

Roy has contributed to the development of policy with respect to medical devices working with committees at the TGA in Australia as an external adviser for industry.

Roy has a Bachelor of Science, Masters of Applied Science in Pharmacy (by research in Drug Metabolism)- Masters of Wellness (Complementary and Alternative Medicine)- Post Graduate of Business and Marketing - Post Graduate of Sales Management, Certificate 4 in work place training and assessment -Currently completing a Phd in Psychopharmacology by research at Swinburne University in Melbourne.