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Hi my name is Dr Roy Hardman and I live in Melbourne, Australia and work around the world.
I have over 35 years of extensive experience within the Medical and Dental Markets in Australia, New Zealand and around the world.
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,TESOL
- Phd in Psychopharmacology by research (Cognitive Neuroscience)
External self-employed agent for sponsors to the Therapeutic Goods Administration in Australia.
Registered with Medsafe in New Zealand.
I currently work with over 300 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.
I have comprehensive experience with the regulatory requirements in EU and Australia and New Zealand. Also worked with regulatory requirements with the FDA.
I have 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.
With the inclusion of devices on to the Australian Register of Therapeutic Goods with respect to Class I, Class Is, Class Im, Class IIa, Class IIb, Class III and AIMDS (Active Implantable Medical Devices) as well as IVD”S. ( In-vitro Diagnostics) including the requirements for disinfectants for both devices and Hospital Grade. In addition to conducting conformity assessments with the TGA for both Bovine and Porcine deactivated tissue within this area. I also prepare Declarations of manufacturers conformity to the Australian standard as well as preparing Safety data sheets (SDS) documents to the Australian standard.
AI have consulted and been involved with industry to gain manufacturing conformity assessment and research trial requirements