Services
Determining the correct regulatory category for your products can be a challenge, but one that MKK Consulting Services can help with.
Cosmetics (AU)
AICIS administration, ingredient notifications, cosmetic claims, labelling requirements and navigating the fine line between cosmetic and therapeutic goods, consultation responses, government liaison
Listed Medicines (AU)
Evidence packages, formulation/ingredients reviews, labelling, advertising, listing applications, GMP clearance applications, GMP/manufacturing advice, pharmacovigilance advice, consultation responses, government liaison
Foods (AU/NZ)
Formulation/ingredient reviews, labelling, advertising, health claims, evidence reviews, consultation responses, government liaison
Dietary supplements (NZ)
Formulation/ingredient reviews, labelling, advertising, health claims, evidence reviews, Trans-Tasman advice, government liaison
We can assist with the creation, review or general advice for the following:
Claim substantiation & evidence summaries
Listing applications (TGA)
Documentation (e.g. Specifications, SOPs, CoA)
We can review or give general advice for the following:
Formulation/recipe
GMP/Manufacturing advice
Market access strategies
Labelling and packaging
Stability protocol
Advertising and marketing strategies and materials
We can also work on your behalf to liaise with the regulators, contract manufacturers, and raw material suppliers, or to prepare and submit consultation responses.
Get to market – stay on market!
Memberships
Complementary Medicines Australia (CMA)
Australian Therapeutic Goods Consultants (ATGC)