Advantage Medical Products Consulting commenced operations in 2000. Founder Brenley M Milsom is a registered pharmacist, with over twenty five years experience in regulatory affairs. Bren identified a number of areas where he felt there were specific markets, which could be better serviced if he applied his extensive knowledge and abilities.
Bren’s background includes almost fifteen years with the TGA; eight years in the medical devices program, two years as secretary to the Australian Drug Evaluation Committee (ADEC) and five years working with over-the-counter (OTC medicines, and other aspects of the therapeutic goods program. A further two years were spent as Technical Director of the Complementary Health Care Council of Australia.
Bren can guide you through the process of application and evaluation of prescription and non-prescription medicines. He will also advise on advertising and claims for complementary medicines and review advertising copy and websites for compliance with the therapeutic goods advertising code. Assistance can also be given with pharmacovigilance, problem reports and recalls.
Brenley C Milsom joined Advantage Medical Products Consulting in 2003. Brenley has a BSc (molecular biology/biochemistry) and has extensive experience in Australian & New Zealand Regulatory Affairs. He can provide guidance and advice on;
- Medical device & In Vitro Diagnostic device conformity assessment – preparation of dossiers and submissions. Experience with a wide range of active & implantable devices, devices containing medicinal substances and devices containing substances of animal, microbial & recombinant origin.
- Medical device & In Vitro Diagnostic device inclusion on the ARTG – preparation & submission of applications, application audits, variations and post-market reporting requirements. Guidance and advice on WAND notifications for New Zealand.
- Biologicals – guidance and advice on technical and GMP requirements for approval of new biologicals (human tissues & cells).
- Manufacturer GMP – application for GMP clearance and submissions including desktop audits.
- Complementary medicines – guidance on acceptable presentation, labelling, formulation, specifications, indications & claims and literature searches. Applications for listing on the ARTG and responses to post-market reviews.
- Over the Counter (OTC) medicines – guidance on presentation, labelling, formulation, specifications and preparation of submissions. New registration applications, clone applications and change applications.
- Export Certificates – applications for export and free sales certificates, authentications and apostilles.
- Disinfectants – preparation of submissions for listed and registered disinfectants as well as medical device disinfectants. Advice on testing requirements, labelling and acceptable claims.
- Cosmetics – advice on presentation and acceptable claims, NICNAS requirements and notifications.
- Advertising – compliance with the Therapeutic Goods Advertising Code and acceptable presentation.
- Safety Data Sheets – guidance and advice on hazard classifications and dangerous goods status, formatting and content of safety data sheets.
Anthony Zirilli joined the Advantage Medical Products Consulting team in 2012 as a consultant. Anthony has a BPharm (Pharmacy) and a BMedSci (Pathology) and has worked in both fields of pharmacy and pathology extensively since 2001 in multiple capacities. Anthony has experience with all government online systems and can help you with medical device inclusions, complementary medicines listings, export certification, GMDN coding, manufacturer registration. This includes dealing with New Zealand’s WAND system for registration of medical devices. Anthony can help prepare submissions for complementary medicines and OTC listings, as well as formulating responses in accordance with TGA and MEDSAFE requests. He will also advise on advertising and claims for complementary medicines, and review advertising material and websites for compliance with the therapeutic foods advertising code, and conduct literature searches to satisfy evidentiary obligations.