TGAACMATurnkey

Your health product, developed and approved for Australia.

We develop supplements, medicines and health devices as turnkey projects, arrange contract manufacturing with TGA-licensed partners, then take them through TGA and ACMA. One team from first formula to first sale.

Paid consults only. You leave with a pathway, a document list and an indicative cost.

SupplementTGA
  • Formula
  • Stability
  • Evidence file
  • TGO 92 label
  • ARTG listed
AUST L 000000
Face serumAICIS
  • Claims check
  • INCI ingredient list
  • Preservative test
  • AICIS registered
  • ACCC label
WE WORK ACROSSTGAACMAAICISFSANZAPVMAPIC/S GMPISO 13485

What we do

Three jobs most brands hire three firms for

TGAAUST L

Listed medicines (AUST L)

Vitamins, herbals, supplements and creams listed on the ARTG. Ingredients, claims, evidence, TGO 92 label and listing. AUST L(A) and AUST R for stronger claims.

ACMA

Electronics and the RCM

EMC, radio and electrical safety for anything with a battery, plug or wireless. The approval people still call “Austel”.

Turnkey

Turnkey solutions

Tablets, capsules, gummies, powders, liquids and topicals through TGA-licensed GMP contract manufacturers. We manage the project and build the regulatory file alongside.

Ready formulas

Pre-developed AUST L formulas, ready for your brand

The formula, ingredient check and stability work are done. You add your brand, we list it.

FlagshipAUST L or AUST L(A)Capsules

Sleep support capsules

Magnesium · Passionflower · Valerian · Hops

Already done

  • Formula and specification
  • Ingredient check
  • Stability data
  • Evidence pack for the claims
  • GMP partner booked

You add

  • Brand name and artwork
  • Pack size and quantity
  • Sponsor details
Claim
General sleep claim, chosen from TGA’s permitted indications
TGA review
None before sale. You certify, TGA can review later
Time to shelf
Shortest. Listing goes live soon after submission
Best for
Fast launch, lowest cost
Ask about this formula
AUST LTablets

Stress & calm

Withania · Magnesium · B vitamins · Lemon balm

Claim areaStress, nervous tension, mild anxiety

Formula ready

AUST LPowder

Magnesium

Magnesium · Vitamin B6

Claim areaMuscle cramps, muscle function, energy

Formula ready

AUST LTablets

Zinc + Vitamin C

Zinc · Vitamin C

Claim areaImmune system health

Formula ready

AUST LCream

Skin relief cream

Colloidal oatmeal · Calendula · Aloe

Claim areaDry, itchy skin. Symptoms of mild eczema and psoriasis

Formula ready

TGA + ACMA

Connected health products need both regulators

TGA inclusion doesn’t cover the RCM, and the RCM doesn’t cover TGA. Most consultants do one. We run both in a single project.

ProductTGAACMA
Zinc + Vitamin C tabletsAUST L listed medicineNot needed
Sleep support capsulesAUST L listed medicineNot needed
Magnesium powderAUST L listed medicineNot needed
Massage gunUsually consumer goodsEMC · EESS charger
Indicative only. Your claims and design decide what applies.

Pathway finder

Which regulators apply to your product?

Answer four questions for an indicative pathway. Your consult confirms it.

Example answers are pre-selected. Change them to match your product.

01What are you bringing to market?
02What will the label or ads claim?
03Does it have electronics?
04Who will produce it?

Turnkey process

How a project runs, from consult to shelf

  1. Consult & NDA

    $150. We map your product to the right regulators and pathway. If you go ahead, we sign an NDA.

  2. Scope & quote

    Written scope, timeline and fixed quote.

  3. Formulation

    Our lab develops the formula and runs stability.

  4. Evidence & label

    Evidence file, claims and compliant artwork.

  5. Contract manufacture

    Produced and released by a TGA-licensed GMP partner.

  6. Listing & marks

    ARTG entry, ACMA supplier registration and RCM.

  7. After launch

    Advertising review, safety reporting and annual charges.

Example project EP-2026-014
is 51% complete.
Client login

Seven stages to market; every one in view.

Where your product sits, right now.

Each ring is one stage, from paid consult to launch. Solid rings are complete, blue rings are in progress and dotted rings are still to come. The orb marks the current stage.

  • Complete
  • In progress
  • Not started
  • Waiting on you
  • Target launchIn 48 days
  • 07 After launchNot started
  • 06 Listing & marksNot started
  • 05 Contract manufactureNot started
  • 04 Evidence & label90% · Waiting on you
  • 03 Formulation70% · In progress
  • 02 Scope & quoteComplete
  • 01 Consult & NDAComplete
Sample data from the example project in the client portal.

Client portal

Progress you can see at a glance

Every client sees work done against time used, the stage they’re at and anything waiting on them.

Project:
Zinc + Vitamin C tablets
Pathway:
TGA · AUST L · Turnkey
Stage:
4 of 7 · Evidence & label
Work complete51%
Time used, start to launch56%

On paceWork is in line with time used.

11/23Tasks done
48Days to launch
1Waiting on you

Frosted arc = work complete. Thin grey arc = time used. Sample data from the example project in the client portal.

Services

Every pathway, one team

Consults

Why our consults are paid

A consult is real regulatory work, not a sales call. You get a specialist’s answer on your product, in writing.

  • 45-minute video call with a regulatory specialist
  • Which regulators apply and the pathway for each
  • The evidence, testing and documents you’ll need
  • Indicative cost and timeline
  • Written summary after the call

Regulatory consult

$150AUD

Book a consult

Not ready? Try the pathway finder first.

Confidentiality

Your product stays confidential

We don’t publish client names, products or results. Every project is covered by a non-disclosure agreement.

NDA

Signed with every client

What you share in your consult is treated as confidential. If you go ahead, we sign a non-disclosure agreement during or straight after it.

Non-disclosure

Your information stays with us

Formulas, suppliers, test data, artwork and launch plans are never shared with other clients. Regulators and your approved partners see only what your project needs.

Discretion

No client lists or case studies

We don’t name the brands we work with. That’s why you won’t find a portfolio on this site.

FAQ

Common questions

Regulatory updates, monthly

TGA and ACMA changes that affect your products, in plain English.