Questions, answered plainly.
Most projects begin with the same handful of questions. These are the honest answers — including the things we do not do.
Approachable enough to start with a question. Technically equipped to turn it into a product. Structured enough to carry it through a pilot run.
The laboratory
What the work is, and where it starts.
What does Exordium Biotech do?
We are a product-development laboratory. The work runs across four connected disciplines: scientific research, formulation, product development and pilot production.
Some projects arrive as a question and leave as a documented, manufacturable product. Others arrive as an existing product that needs technical repair or a clearer route to production. Both are normal.
What makes Exordium different from a contract manufacturer?
We start earlier. A contract manufacturer generally begins once a formula exists; we begin at the research and chemistry stage, where the question is still whether the product can work at all.
That means literature and ingredient investigation, formulation development, prototype iteration and then a controlled pilot run — with direct access to the people making the technical decisions rather than an account layer between you and the bench.
Who is a good fit for the laboratory?
Founders and emerging brands building a first product, established brands developing something new or fixing something that stopped working, inventors and biotech teams with an unusual technical problem, and practices, clinics, spas and beauty brands developing products under their own name.
Projects are reviewed for technical fit, development readiness and current laboratory capacity — not for company size.
Do you only work with startups?
No. Accessibility to early-stage founders is deliberate, but a good share of the work is for established brands: new product development, reformulation, technical problem-solving, pilot runs, or preparing a product to move to a new production partner.
Where are you located, and who do you work with?
The laboratory is based in Northern California, in Sonoma County, and works with clients across the United States. Most development runs remotely through written technical documentation, samples and review calls.
Scope of work
What we can develop, and what we do not do.
What types of products can you develop?
Dietary supplements in capsule, powder, liquid and gummy formats; skincare, cosmetics and topical products; and specialty formulations that do not sit neatly in one category.
Cross-category work is a strength — the same formulation principles of solubility, stability, dose and delivery apply whether the product is swallowed or applied.
What services do you offer?
Scientific and literature research, ingredient intelligence and feasibility work; formulation and R&D; product development with prototype and revision cycles; packaging and format compatibility support; coordination of analytical and stability testing through qualified third-party laboratories; and development-scale pilot production.
Private-label and starting-formula work is available selectively, but it is a secondary capability rather than the centre of the practice.
Can you help with research before there is a formula?
Yes, and this is often where the most value is created. Research work covers published literature, mechanism plausibility, ingredient and material intelligence, technical landscape review and feasibility — the evidence position behind a product decision.
This is technical and formulation research. It is not clinical research, and it is not medical advice or medical services.
Do I need to already have a formula?
No. Projects start from four places: a question or idea, a written product brief, an existing formula that needs development, or a finished product that needs technical improvement or a new production route.
The six-step brief is designed so that not knowing the answers yet is a valid starting position.
Can you help if my current formula is not working?
Usually, yes. Common cases are separation or settling, potency loss over time, sensory problems, texture or fill behaviour, incompatibility between actives and the vehicle, cost pressure, or a formula a manufacturer cannot reproduce consistently.
The first step is diagnosis: what is actually failing, and whether it is a formula problem, a process problem or a packaging problem. We do not promise a fix before understanding which one it is.
Can you help with packaging?
We treat packaging as part of development rather than an afterthought: format and delivery selection, compatibility between the formula and the container, fill and dose behaviour, and how the presentation holds up in a pilot run.
We are not a packaging manufacturer or a fulfilment operation, so sourcing and print production sit with your suppliers.
Do you offer private-label products?
Selectively. A starting formula can be an efficient route for a straightforward product, and we will say so when it is. But the practice is built around custom research, formulation and development, so private label is a limited option rather than a catalogue.
What happens to the information and technical detail I send?
It is used to review the project and reply to you — nothing more. We do not sell information, run advertising trackers or add you to a mailing list because you contacted us.
Formulas and technical detail are treated as confidential business information. Confidentiality, formula ownership and intellectual property in project deliverables are defined in the applicable project agreement.
Do you develop CBD products?
No. CBD product development is not currently offered.
Claims & regulatory
Compliance and claims review — technical support during development, not legal advice.
Can Exordium review my product claims?
Yes. Compliance and claims review reads the language you intend to use — on the label, the packaging, the website and in marketing — against what the formula and the available evidence actually support.
The output is written, claim-by-claim observations: what looks supportable, what reads as higher risk, and where wording could be brought closer to the product. It is technical product-development support, not legal advice.
Can you review supplement labels and structure/function claims?
Yes, as part of development or as a standalone review. That covers panel content, ingredient declaration, directions and warnings, plus the claim language printed alongside them.
Structure/function claim considerations are handled carefully: language describing an effect on normal structure or function sits in a different place from language describing treating or preventing a condition, and we will flag where a draft crosses that line.
Can you help determine whether cosmetic language risks becoming a drug claim?
That is one of the most common reasons brands ask for a review. A skincare product described in terms of appearance generally reads as a cosmetic; the same product described as treating a condition or changing physiology can read very differently.
We identify where the draft language, the ingredient story or the marketing copy pushes toward that boundary, and suggest phrasing closer to what the formulation supports. Where the answer is genuinely contested, the right next step is a specialist.
Do you provide FDA regulatory support?
We provide FDA regulatory research and claims review as part of product development: reviewing ingredients, labels, packaging and marketing language for obvious regulatory concerns, and researching the labelling considerations relevant to your category.
We do not represent anyone before the FDA, make submissions or registrations, or act as a regulatory agent. Where a matter needs legal advice or specialist representation, we say so and it goes to an outside specialist or attorney.
Does Exordium guarantee FDA compliance or approval?
No. Nobody can. Claims review helps identify regulatory considerations before language reaches a label, package or website, and it reduces the number of obvious problems — it does not guarantee that any agency will agree with a decision.
There is no FDA approval, certification or endorsement of a dietary supplement or cosmetic to obtain, and we have no affiliation with the agency. Responsibility for what is published stays with the brand.
Can you review claims for a product you did not develop?
Yes. A standalone review works from whatever exists — the ingredient list or formula, draft label copy, artwork or the live product page.
Select compliance and claims review as your starting point in the brief and describe what you already have.
Pilot production
Why development-scale runs are treated as part of the science.
What is your minimum order quantity?
The laboratory is set up for development-scale pilot production — typically 100–500 units where the format and equipment allow, rather than a fixed catalogue minimum.
That quantity exists for a technical reason: it is enough product to evaluate the process, the packaging and early commercial response without committing to an inventory position before the product has been proven.
Why do you work in smaller pilot batches?
A pilot run is an experiment with a saleable output. It exposes what a bench sample cannot: whether the process repeats, how the formula behaves in the actual container, what real fill weights and yields look like, and what the unit economics really are.
It also produces units for controlled feedback before a scale decision. The exact quantity depends on the format and category — 100–500 is a typical range, not a universal rule.
Can you manufacture the product after development?
Pilot production is offered directly. Beyond pilot scale, ongoing commercial production is scoped project by project, based on the format, volume and process requirements, and is often best placed with a production partner working from the documentation the development produced.
A properly documented formula, specification and process is what makes that transition possible without redeveloping the product.
Working together
Cost, timing, confidentiality and testing.
How much does a project cost?
There is no published price list, because the variables genuinely change the number: research depth, formulation complexity, number of prototype rounds and SKUs, testing requirements, packaging work and production scope.
A brief lets us assess scope and respond with a proposal that reflects the actual project rather than a generic package.
Do you charge for research and formulation work?
Research, formulation and development are scoped as professional project work rather than free pre-sales activity, and the terms are set out in a proposal before the work begins.
Reviewing a brief and discussing fit costs nothing.
How long does product development take?
It depends on the work in front of it — research depth, formulation complexity, how many revision rounds a prototype needs, ingredient sourcing lead times, packaging decisions, testing and any regulatory review on your side.
A straightforward reformulation can move quickly; a novel format or an unfamiliar active takes longer. A project-specific timeline is given after the brief is reviewed, rather than promised in advance.
Do you provide testing?
Applicable analytical and stability testing is coordinated through qualified third-party laboratories rather than performed in-house. The scope depends on the product, its category and what the project needs to demonstrate.
Coordinating it as part of development keeps the test plan tied to the technical questions that actually matter for the formula.
How do you handle quality and documentation?
Development is recorded as it happens: formula versions with the reason for each change, process steps, observations, packaging decisions and the results of coordinated third-party testing.
The output is a specification a manufacturer can execute. Any certification claims will be published only with verified supporting documentation.
Who owns the formula and the intellectual property?
Ownership of the formula, the intellectual property and the project deliverables is defined in the applicable project agreement, and is agreed in writing before development work begins.
Confidential technical information you share is treated as confidential.
Will you sign an NDA?
Confidentiality requirements can be discussed during project review and documented where appropriate. If a signed agreement needs to be in place before you describe the project in detail, say so in the brief and we will handle that first.
Getting started
What to prepare, and what happens next.
What should I have ready before contacting you?
An objective is enough. If you can describe the problem you want the product to solve, that is a workable starting point.
Anything else is a bonus: benchmark products you admire, a preferred format, ingredients you want included or avoided, an existing formula or specification, packaging ideas, target quantity, timeline and budget constraints. Missing items are normal at this stage.
What happens after I submit a project brief?
The brief is reviewed for scope, technical fit and current capacity. If it is a fit, we follow up to clarify requirements and agree an appropriate next step — usually a scoped proposal covering the research or formulation phase.
The brief builds a preliminary target product profile from your answers. It is a working sketch to structure the review, not a finalised technical specification.
While this site is being finalised, brief delivery is not yet connected — the answers stay in your browser. Email is the reliable route in the meantime.
Still unanswered
A question is a perfectly good place to begin.
If your situation is not covered here, describe it in the brief. Open fields and unknowns are expected at this stage — the review exists to work them out.