Engel Hellyer & Partners

Engel Hellyer & Partners is one of Australia’s most experienced and trusted regulatory affairs consultancies for pharmaceuticals, medical devices, chemicals (including cosmetics and disinfectants), complementary medicines, foods and supplements[1][3][5][7]. They have over 40 years of experience supporting clients with successful submissions to the Therapeutic Goods Administration (TGA) and Australian Industrial Chemicals Introduction Scheme (AICIS)[1][4][5].

Their services include compliance reviews for thousands of products annually across multiple regulated categories such as cosmetics regulation/compliance checks, medical device classification support, food standards conformity assessments (FSANZ), advice on claims/packaging/labeling/import/export/manufacturing/marketing regulations in Australia[1][3]. Their team includes experts in chemistry, pharmacology, toxicology, biology, medicine and law[5].

The firm works with both large multinationals and SMEs to ensure regulatory compliance from product development through market entry.

They do not develop their own therapeutic products or technologies but are recognized leaders in technical regulatory consulting.

No clinical results or pipeline programs exist as they are a consultancy rather than a product developer.