MKK Consulting Services

MKK Consulting Services is a dedicated and responsive consultancy agency, providing personalised regulatory services and solutions. We have more than 20 years of experience in regulatory affairs, quality control and testing environments for therapeutic, food and cosmetic products for both Australia and New Zealand markets. We support businesses wanting to bring listed complementary medicines, such as vitamins, minerals and herbal products, to market in Australia and New Zealand, with projects from development through to implementation and ongoing obligations.

Services

Meet Melanie Kevern

Navigating regulatory pathways and requirements can be daunting, and the rules are constantly shifting. We’re here to help make the regulatory development and execution of your projects, and any ongoing compliance requirements, as painless as possible.
With a passion for science and regulation of complementary medicines, foods and cosmetics, we work with you to bring your products to market quickly and with personal service tailored to your needs.
My experience and involvement with industry and regulators can help guide market access for your products and promotional material while balancing the government expectations for regulatory and safety compliance.
Ultimately, it’s my belief that people deserve a greater choice in managing their own self-care, including healthcare, nutrition and hygiene which inspires me to work hard for my clients.
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Consultation responses that keep your business and your consumers in mind

We are an end-to-end services provider and can assist with simple administration style services to more involved scientific review of evidence and regulatory strategy. We can assist 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
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Listed Medicines (AU)

Evidence packages, formulation/ingredients reviews, labelling, advertising, listing applications, GMP clearance applications, GMP/manufacturing advice, pharmacovigilance advice, consultation responses, government liaison
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Foods (AU/NZ)

Formulation/ingredient reviews, labelling, advertising, health claims, evidence reviews, consultation responses, government liaison
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Dietary supplements (NZ)

Formulation/ingredient reviews, labelling, advertising, health claims, evidence reviews, Trans-Tasman advice, government liaison
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Think of us as your one-stop shop for regulatory services, strategy and support.

Pharmacovigilance

We can offer guidance as to what your obligations are regarding pharmacovigilance.

Client Testimonial

Mel’s expertise in navigating TGA requirements and regulatory changes has been invaluable, particularly for a business based primarily outside Australia. Our business would not have been able to navigate the changing environment over the last year without her.

Penelope

New Zealand

I have used MKK Consulting Services for specialist projects for listed complementary medicines over the last two years, including preparing claim substantiation for potential new product ingredients, formula and promotional materials review. I have found the service provided by Melanie/MKK Consulting Service excellent, timely and comprehensive, providing ideas and options for how to address potential compliance issues.

Nicole

Brisbane

Our company recently required urgent support to cover staff on maternity leave. I found MKK Consulting to be more than just a reliable source of assistance. They are punctual, enthusiastic and flexible. Most importantly, Melanie was able to come in cold on some complex issues, pick up where my staff had left off and continue on seamlessly with the work.

Michael

Brisbane

Blog

Therapeutic Goods Advertising Code and associated guidelines update:

Therapeutic Goods Advertising Code and associated guidelines update:The Therapeutic Goods Advertising Code 2021 came into effect on the 1st of January 2022. There is a 6-month period for advertisers to transition their advertising materials to the amended advertising...

Therapeutic Goods Advertising Code Guidelines:

The TGA have published guidance for the recent advertising code update: Therapeutic Goods Advertising Code 2021. If you would like some regulatory support or advice to update your advertising materials to the new code please do not hesitate to get in contact....

Update to listed medicine ingredients in March 2022

Update to listed medicine ingredients in March 2022

An update to listed medicine ingredients and requirements for their use has just come into effect (01 March 2022).For a list of changes to the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2022 please click the link below.#PermissibleIngredients...

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