Signature Labs · New Product Development
Nutraceutical product development turns an idea into a product a manufacturer can make and a regulator will accept. We define the product, choose the format, set the regulatory pathway, plan prototypes and hand you a specification that contract manufacturers can quote against.
Markets
AU · US · UAE
Timeline
From 8 weeks
You receive
A scoped product brief
Three questions. We show the services your product needs to get from idea to quote.
Starting from this service
Your pathway
Question 1 of 3
What this covers
New product development is where most founder-led brands either save or lose the most money. Choices made early, such as the format, the number of actives, the claims and the target market, decide what the product will cost to make, how long it takes to reach shelves and whether it can be sold where you want it.
We start with the product brief: who it is for, what it should do, what it should cost and where it will sell. From there we choose the format and dosage, outline the formula direction, confirm the regulatory pathway for each market and plan prototypes. Formulation itself is a separate service when you need a full, evidence-led formula; many clients take both.
The finished output is a specification a contract manufacturer can quote against, with the regulatory route already settled. That means quotes you can compare, fewer surprises in sampling and a product that does not need to be reworked once it is made.
Development is also where the regulatory route is cheapest to change. Adding a claim, a new market or an unusual ingredient after the specification is signed can mean new evidence, new labels and new quotes. We test those decisions early, so the product that goes to manufacturers is the one you can sell in Australia, the United States or the UAE without a second round of development.
DSHEA status for every ingredient, with NDI questions flagged.
Panel, statement of identity and required label copy, laid out for your designer.
Claims, substantiation and the 30-day FDA notification.
Website, ads and marketplace listings checked against FDA and FTC rules.
Supplier and manufacturer paperwork reviewed against 21 CFR 111.
What an FDA inspector would ask for, and where it lives.
How it works
Every New Product Development scope follows the same four stages. You receive a written output at the end of each, so nothing depends on memory or a phone call.
Discovery
We learn the product, where it is sold today and how you plan to sell it in the US.
Written output: Discovery notes
Validation
Each ingredient, dose and claim is checked against DSHEA, FDA labelling rules and FTC guidance.
Written output: Validation report
Scope
We set out exactly what will be prepared, by whom, and when you will have it.
Written output: Signed scope
Build
Label, claims file, notifications and marketing review, delivered to the scope.
Written output: Final compliance file
Who this is for
Listed medicines, from single actives to complex multis.
Strain selection, stability and claim wording..
Protein, pre-workout and recovery, food or medicine.
Cognitive claims handled with care.
FSANZ standards for foods that do more.
Collagen, skin and hair from the inside.
A note from Amelia
Often scoped together
Direct time with Amelia for founders building a first product.
Questions
If your question isn’t here, send it with your enquiry. We reply within two business days.
It is the process of turning a product idea into a specification that can be manufactured and legally sold. It covers the product brief, format, formula direction, regulatory pathway, prototypes and costs.
Ours has four stages: discovery, validation, scope and build. We learn the idea, test the format, formula direction and regulatory route, agree a written scope, then deliver a specification and prototype plan a manufacturer can quote against.
It depends on the format, the number of actives, the markets and how much testing is needed. We give you a written estimate for development and first production as part of the scope, before you commit to a manufacturer.
We plan and manage prototypes with manufacturers we have vetted. We are not a manufacturer ourselves, which means our recommendations are based on your product, not on filling our own production lines.
Yes. Functional foods follow the FSANZ Food Standards Code in Australia and food rules in the US, so the pathway and claims differ from supplements. We confirm the right route at the start.
A formula that suits young adults in Sydney may not suit older adults in Los Angeles or families in Dubai. Nutrient needs, diets, cultural requirements, climate and local rules all shift from one population to the next. Here is how we approach reformulating a supplement so it fits the people who will take it.
Expanding a supplement brand into a second or third country is rarely a copy and paste job. Each market brings its own rules for ingredients, claims, labels and post-market duties. Here is how we help brands sequence their markets, build once and scale without losing control of compliance.
A compliant label does not make a compliant listing. Product pages on Amazon and Shopify carry claims, images and keywords that regulators and marketplaces treat just as seriously as your pack. Here is why your listings deserve the same review as your label, and what to check before you hit publish.
Add collagen to coffee and you might think you have made a supplement. In most cases, regulators see a food. That changes the label, the ingredients you can use and the claims you can make. Here is how classification works for functional foods in Australia and the US, and why it matters early.
Your scope
Services you add appear here and are sent with your enquiry. We reply within two business days with fixed fees.
