Brenley (Bren) Milsom (Senior)
ADVANTAGEMPC commenced operations in 2000. Founder Brenley M Milsom is a registered pharmacist, with over twenty 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 as 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 Milsom
Brenley C Milsom joined the consultancy in 2003. Brenley has a BSc (molecular biology/biochemistry) and is experienced with all government on-line systems. These include manufacturer registration and medical device & diagnostics inclusions, medicines updates, complementary medicines listings, GMP pre-clearances, Export Certification GMDN Coding, AICS notifications and New Zealand’s WAND and COMET systems.
Brenley can make your Listings of Complementary Medicines simple. He will assist you with label compliance, preparing tables of evidence in support of therapeutic claims and responses to TGA post-listing audits.
Brenley has successfully steered through numerous Class III Medical Device inclusions and can help you prepare your Technical Documentation for Device Technical Files and applications for Conformity Assessment. He is also experienced with preparing responses for TGA Level 1 and Level 2 device application audits.