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Holistic Approach: We view dietary supplements as part of a larger wellness ​strategy, considering formulation, safety, and regulations.

Expertise at Every Stage: Our team possesses deep knowledge of regulations, ​ingredients, and best practices throughout the development process.

Accountability to You: We prioritize transparency and clear communication, ​keeping you informed throughout the compliance journey.

Legality First: Your product's safety and compliance are paramount, ensuring ​you navigate regulations with confidence.

Trustworthy Partner: We build strong relationships based on reliability and ​integrity, becoming an extension of your team.

Health & Well-being Focused: Our core mission is to ensure your dietary ​supplements contribute positively to consumer health.

HealthREG Solutions Group is are the regulatory experts in over 15 countries , don’t see your market here ?

Contact Us for a full market list.

REGULATORY COMPLIANCE

Our industry-leading regulatory consulting service provides a tailor-made ​solution to ensure your listed medicines, dietary supplements, cosmetics, ​prescriptions, and medical devices comply with international regulations.

From Breakthrough Innovations to Everyday Essentials:

We offer comprehensive support for a wide range of products, including:

• Listed Medicines
  
• Dietary Supplements
  
• Cosmetics
  
• Foods
• Prescription Drugs
  
• Medical Devices
  

Our experienced team can guide you through the entire process, from ​concept development to market launch, guaranteeing your product meets ​all necessary safety and efficacy standards.

Whether you're a budding startup or a well-established brand, we provide ​the end-to-end support you need to navigate the complexities of ​regulatory compliance. Our commitment to client success has established ​us as a highly-regarded consultancy firm across the globe.

MANUFACTURING , AUDITING & BRAND GROWTH SERVICES

At HealthREG , you are not just a client , we see you as a partner with many of our clients starting with us as staying with us through their journey into the market.

As you grow we can assist you with international manufacturing , GMP auditing , brand growth strategies through our partner consultancy Wellife Health, with a full internal and international in house quality assurance and quality control department to ensure that your products are manufactured exactly how they should be , to our strict requirements , giving you piece of mind as your product moves internationally.

We specialize in auditing , manufacturing services such as :

• HACCAP Auditing
  
• GMP Clearance Pre Audit
• GMP Auditing Europe, FDA , Health Canada & TGA
• Gap Analysis and Dossier Auditing for OTC and Prescriptions.
• QMS and EQMS Gap Analysis and Dossier Auditing for Medical Devices.

Interested in growing your brand internationall ? Contact the team today for a personalised Brand Growth Regulatory Pathway report , so you can get to market sooner , without any unexpected suprises.

COSMETICS & HAIR CARE

Our regulatory consulting service removes the guesswork from bringing ​your cosmetic and AHC (Animal Health Care) products to market. We ​provide a custom-designed plan that ensures your formulations adhere to ​international regulations.

From Concept to Compliant Shelf Presence:

We offer comprehensive support for both cosmetics and AHC products, ​guiding you through the entire process:

• Concept development & ingredient selection
• Safety assessments & efficacy testing
  
• Regulatory compliance strategy
  
• Labeling & packaging requirements
  
• Market access & registration
  
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Our team of seasoned professionals understands the complexities of ​navigating cosmetic and AHC regulations. We partner with businesses of ​all sizes, from startups to established brands, to ensure a seamless ​transition from concept to compliant product.

Let us be your trusted partner in navigating the ever-evolving ​landscape of cosmetic and AHC regulations. Together, we can turn ​your vision into reality.

Lock in project and start begin Stage 1 Formulation & Claims Development

Book a 15 minute ​discovery call with our ​team

Choose a manufacturer from our quality network or BYO

Sit back and relax while your products registered and manufactured

How do I know if my supplement is TGA or a FOOD ?

The TGA have developed a Food - Medicine Regulatory Tool in order to have consumers and brand owners understand where their products fit - ​we advise our new clients to review this and book a call with us if you require further clarification.

How long is the TGA Process for registration?

From submission of the ARTG Listing and payment of the invoice - generally 3-4 days for digital registration and another 3 days to recieve your ​certificate of registration , TGA run a post audit system for product registration.

Is my Australian product compliant for all international markets?

Depends , UK and USA have differing limits on ingredients and market expectations to Australia , from a claims perspective every market is ​different to AUstralia , so you will not be able to use the same claims generally.

Do I need to do pharmacovigilance for my TGA product?

Yes, its is mandatory for all products listed on the ARTG in Australia and covers product defects , consumer reaction and when your should ​report a reaction.

I want to bring my USA made supplement here to Australia and sell , can you help me ?

Yes we can help , however depending on what category your products its into - this may require TGA registration as well as Overseas ​Manufacturer Clearance, we highly recommend you submit an enquiry so we can personalize your market entry approach.

How long is the process from design to manufacture , so I can plan my launch.

We generally work in with your manufacturer and can also arrange a quotation of your product through our vetted manufacturing network. The ​general lead time for manufacturing a TGA product is 12-14 weeks , Stage 1 of Formulation & Claims development wil only add one week to this ​process , however ots best to book a call with us as timelines as subject to project booked as approvals.