HealthReg Solutions Group
End-to-end regulatory guidance for supplement, cosmetic and medical device brands across Australia and internationally.
The Problem
You have a product concept. You know the market wants it. But between TGA requirements, classification decisions, formulation compliance and labelling rules, the path from idea to shelf is anything but clear.
Most brands hit the same walls: conflicting advice from multiple providers, unclear timelines, costly rework, and the risk of getting it wrong at a stage where mistakes are expensive.
You need a regulatory partner who can see the full picture, not just one piece of the puzzle.
The Solution
HealthReg Solutions Group provides end-to-end regulatory support across supplements, cosmetics and medical devices. From your first product concept through to post-market compliance, you work with one team that handles every stage.
From concept design and ingredient compliance through to TGA registration and label review. One team, one process, no referrals.
Local and global regulatory support. Enter new markets without engaging a separate consultancy in each country.
Ongoing pharmacovigilance, adverse event reporting and regulatory updates, so your product stays compliant after launch.
Services
TGA registration, product classification, claims review and compliance for dietary supplements and complementary medicines. Whether your product sits in a grey area between food and therapeutic, or you need a clear path to an AUST L listing, we guide you through every requirement.
Ingredient compliance, label review and claims substantiation for beauty and personal care brands. Navigate AICIS chemical assessments, stay current with regulatory changes, and bring a compliant formulation to market.
TGA classification, inclusion applications and post-market surveillance for medical devices and IVDs. From understanding whether your product is Class I, II or III through to a complete regulatory submission, we provide the clarity this category demands.
Ready-made supplement formulations, contract manufacturing and private-label options. When you need a product, not just advice.
Regulatory-led formulation development from concept through to manufacturing handover. We check ingredients, dosages and stability for both performance and compliance before you invest in production.
Market entry roadmaps for Australia and international markets. We map the regulatory pathway, timeline and costs from classification through to retail readiness, so you launch without gaps or surprises.
Pre-launch and post-launch review of labels, packaging and marketing claims against TGA, ACCC and advertising code requirements. We flag issues and provide compliant alternatives that protect your messaging.
Why HealthReg
HealthReg Solutions Group has been guiding health product brands through Australian and international regulatory requirements since 2018. That track record means fewer surprises for you and more situations we have already navigated.
Most consultancies stop at registration. We stay with you from formulation through manufacturing, market entry and post-market compliance. No referrals to third parties, no gaps between stages, and no handovers where your project context gets lost.
Australian regulatory expertise with international market entry support. Enter new countries without managing multiple consultancies.
Every engagement produces a decision you can act on, not a compliance essay. We speak plain English and keep your project moving.
Who we work with
You have a concept but need clear guidance on what is legally required before you invest in manufacturing. We take the guesswork out of your first product launch.
You are expanding your range, entering new channels or preparing for international markets. We provide the regulatory support that keeps pace with your growth.
You need reliable regulatory capacity across multiple products and markets without hiring a full internal team. We operate as your outsourced regulatory department.
How it works
We learn about your product, your market and your timeline. You learn whether we are the right fit, with no obligation.
We assess your product category, identify the compliance requirements and deliver a clear plan with defined stages and costs. You know exactly what is involved before you commit.
From formulation and registration through to manufacturing oversight and post-market compliance, we handle every regulatory step so you can focus on building your brand.
FAQs
Products commonly known as dietary supplements in other markets are regulated as "Listed Medicines" in Australia. They must be entered in the Australian Register of Therapeutic Goods (ARTG) and comply with strict manufacturing and safety standards, including GMP certification and pharmacovigilance obligations. Each listed medicine receives an "AUST L" identification number that must appear on its label.
International companies cannot hold TGA approvals directly. An Australian Sponsor acts as your legally responsible representative for all TGA dealings, including product safety compliance, pharmacovigilance, adverse event reporting and recall procedures. Without a sponsor, you cannot list products on the ARTG or legally supply therapeutic goods in Australia.
Yes. TGA compliance requires that your manufacturer meets TGA-recognised Good Manufacturing Practice standards. This must be verified and cleared before you can apply for ARTG listing. We verify GMP status as part of our market entry assessment.
Pharmacovigilance is mandatory for all sponsors of therapeutic goods, including AUST L listed medicines. You must have a documented system to monitor, collect and report adverse events to the TGA, manage product complaints and ensure ongoing safety compliance. The TGA requires three separate reporting streams: Significant Safety Issues (SSIs) must be notified within 72 hours of awareness; Individual Case Safety Reports (ICSRs) for serious adverse reactions must be submitted within 15 calendar days of first receipt; and Other Safety Issues (OSIs), which are confirmed safety concerns that do not meet the SSI threshold, must be notified within 30 calendar days.
The TGA conducts compliance reviews on a regular basis, and listed medicines are selected for review across a range of criteria including complaint history, product category risk and random sampling. Key focus areas include label compliance, advertising claims and online marketing content. Maintaining audit-ready documentation and compliant labelling significantly reduces enforcement risk.
Our 3-Point Registration Check ensures accuracy at every stage: (1) Client Check confirms the draft registration matches your product and your intended claims; (2) Manufacturer Check verifies consistency with the product specification and manufacturing process; (3) HRS Check confirms TGA-specific requirements including ingredient safety, labelling compliance and evidence standards. This three-way verification reduces the risk of post-registration audit issues.
This time is required for an extensive literature review using PICOTS criteria (Population, Intervention, Comparison, Outcome, Time, Study design) to ensure the evidence is robust and specific enough to withstand a TGA post-market audit. Rushing this process increases the risk of rejection or post-market enforcement action.
The TGA primarily focuses on website and label compliance during post-registration audits. If an issue is found, you may be required to update labels, conduct product recalls or face suspension of your ARTG registration. We build audit-ready documentation from the start and provide ongoing compliance monitoring to minimise this risk.
Non-compliance can lead to infringement notices (with penalties calculated per penalty unit, currently $364 as at July 2026), public non-compliance notices, mandatory product recalls or suspension of your ARTG registration. In serious cases, criminal prosecution is possible. Pre-launch review is significantly less costly than enforcement action.
The Australian Register of Therapeutic Goods (ARTG) listing is the mandatory registration required before your product can be legally sold in Australia. It serves as your official "AUST L" number and must be maintained with current specifications, labelling and manufacturing details. Products cannot be legally imported, exported, manufactured or supplied in Australia without an active ARTG entry.
The TGA actively monitors social media for unapproved therapeutic claims, testimonials from health professionals and misleading "before/after" imagery. In the 2024-25 financial year alone, the TGA requested the removal of over 13,700 unlawful advertisements from digital platforms. All marketing, including influencer content, must be truthful, substantiated and consistent with the ARTG entry. Influencers who receive payment or reward (including free products) cannot share personal experience testimonials about therapeutic goods.
Sponsors have three reporting obligations. Significant Safety Issues (SSIs), which are safety concerns likely to warrant urgent regulatory action, must be notified within 72 hours of awareness. Individual Case Safety Reports (ICSRs) for serious Australian adverse reactions must be submitted within 15 calendar days of first receipt. Other Safety Issues (OSIs), which are confirmed safety concerns that do not meet the SSI threshold, must be notified within 30 calendar days. You must also maintain a documented pharmacovigilance system for ongoing monitoring, complaint management and signal detection.
Labels must strictly comply with TGO 92 (the Standard for Labels of Non-Prescription Medicines) and the Therapeutic Goods Advertising Code. Simply importing an overseas label is rarely compliant. We perform a gap analysis to ensure mandatory statements, ingredient declarations and indications match your ARTG entry and meet Australian requirements.
No. There is no centralised registration system for food supplements in the EU or UK. Under Directive 2002/46/EC, each member state sets its own notification requirements. You only need to notify in the specific member states where you intend to sell your product, not across all member states. Some require pre-market notification with label copies; others do not. The UK specifically does not require prior notification for food supplements, though you must register as a Food Business Operator.
The requirements vary by product category. For cosmetics, EU Regulation EC 1223/2009 requires a designated Responsible Person who maintains the Product Information File (the "technical file") and whose address must appear on the product label. For food supplements, the requirement is different: you must register as a Food Business Operator in each market and comply with that market's notification rules, but there is no formal "technical file holder" requirement as there is for cosmetics. For medical devices or therapeutic products, an authorised representative is typically needed. We advise on the specific requirements for your product category and target markets.
Canada regulates natural health products through the Natural and Non-prescription Health Products Directorate. All natural health products require a product licence and Natural Product Number (NPN) before they can be sold. Classification depends on the product's ingredients and intended claims. The regulatory framework, permitted ingredients and claims requirements differ significantly from Australia's TGA pathway.
While we aim for maximum consistency, local regulations often require adjustments to ingredients, overages or label claims. We conduct a pathway assessment for each target market to ensure your core formulation is viable or identify the specific local modifications needed.
We recommend a market entry pathway report. This assesses the regulatory classification of your product (food, supplement, cosmetic, therapeutic good or device) in the target country, identifies the required registration documentation and maps the compliance requirements before you proceed.
Testimonials
Process and timelines
Once we start working together, HealthREG manages your regulatory work from initiation through completion. Clear plans, tracked milestones and regular status updates give you visibility, accountability and certainty about what is happening and when.
From scoping through to sign-off, HealthREG runs the process. We coordinate with your team, your manufacturers and regulators so the work moves forward without stalling on your desk.
Every engagement starts with a written plan that sets out scope, deliverables, milestones and responsible parties. Timelines are tracked as work progresses so you always know how the project is tracking against the plan.
You get regular written status updates covering progress, decisions taken, outstanding actions and upcoming milestones. Nothing waits until the next quarter to surface.
When approvals, submissions or reporting deadlines are due, we tell you what is coming, what we need from you and what happens next. No surprises.
The aim is a well-managed process that gives you certainty about compliance, accountability for delivery and clear visibility of where the project stands at any point in time.
Ready when you are
Whether you are launching your first product or expanding into new markets, the first step is a conversation. Book a free discovery call and we will assess your situation, answer your questions, and outline what a clear path to market looks like for your product.
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