Regulatory Consulting for Therapeutic Goods, Medical Devices, and Consumer Products
Expert guidance across Australia and New Zealand to support product compliance, registration, and market access.
We help businesses navigate complex regulatory frameworks across therapeutics, complementary medicines, medical devices, cosmetics, and food products, ensuring your products are compliant, market-ready, and positioned for success.
What mAce Has Achieved…
900+ Product Approvals
Extensive experience navigating the world's most rigorous regulatory frameworks, including AU, NZ, USA, UK, EU, and SE Asia.
Pioneering Ingredient Approvals
A proven track record in securing New Substance Approvals for the Australian Complementary Medicine market.
Regulator Notice Resolution
Specialised expertise in managing high-pressure TGA & Food Authority notices to achieve resolved, compliant outcomes.
The right time to engage mAce is at any stage of your product lifecycle where regulatory certainty is required. Whether you are in the initial stages of product development and classification or managing ongoing compliance, our comprehensive regulatory consulting services ensure you navigate the complex compliance requirements of Australia and New Zealand with confidence.
Our ServicesWhen is the Right Time to Engage mAce?
Therapeutic Goods
Strategic management of Therapeutic Goods through expert ARTG applications and Technical Dossier preparation, ensuring full compliance with Australian labelling and advertising standards.
Complementary Medicines
From ingredient reviews and ARTG listing applications to creating robust evidence packages for claims, we provide end-to-end labelling and advertising compliance audits and ongoing regulatory support.
Medical Devices
Navigating the full Medical Device lifecycle through device classification, seamless ARTG inclusion, and dedicated regulatory sponsorship support for local and international manufacturers.
Cosmetics
Expert guidance for Cosmetics through AICIS compliance and ingredient checks, managing the complexities of chemical categorisation, pre-introduction reports, and comprehensive labelling and claims reviews.
Food Products
Comprehensive support for Food Products, managing Food Standards Code compliance, labelling, and regulatory assessments, including preparation of Applications to vary the Food Standards Code.
Import Permits for Biological Products
Specialising in BICON permit applications and DAFF regulatory compliance for biological goods. Prepare and secure import permits for plants, animal derived, and related extracts.
New Substance Applications
Preparation and management of New Substance Evaluation applications to secure ingredient approval for TGA listed medicines.
Regulator Notices
Expert management of Regulator Notices and mandatory responses, ensuring your business meets strict deadlines and maintains regulatory compliance.
GMP Compliance
Facilitating GMP compliance, clearances, and certification for overseas manufacturers, including full TGA sponsorship services to ensure your products meet Australian quality standards.
Our Methodology: The 3-Pillar Path to Market
Phase 1
The Roadmap
Avoid costly surprises before you spend a cent.
Phase 2
The Heavy Lifting
We handle the dossiers and technical jargon so your team doesn't have to.
Phase 3
The Guardian
Scale with peace of mind knowing we're watching the legislative shifts for you.
Why Work With UsWe provide practical, expert-led regulatory support backed by extensive industry experience and a proven track record.
We aren't just consultants, we are Strategic Partners who have sat on both sides of the table. Our deep-niche expertise in FMCG, Medical Devices, and Nutraceuticals allows us to navigate the "Grey Areas" with technical precision and commercial common sense.
Proven Track Record
With over 900+ products successfully registered and approved, including new substance evaluation applications, we bring deep, hands-on experience across a wide range of regulatory pathways.
Experienced Regulatory Experts
With 20+ years of combined experience, we understand the complexities of Australian and New Zealand regulatory frameworks, including TGA, AICIS, and food regulations.
End-to-End Support
From early product development through to registration and post-market compliance, we support every stage of your product lifecycle.
Practical, Commercial Advice
Clear, actionable guidance that helps you move forward with confidence, without unnecessary complexity.
Tailored to Your Product
Every product is different. We provide advice specific to your formulation, claims, and market pathway.