What is regulatory documentation?
Regulatory documentation is the evidence layer behind a finished supplement — the official records that prove what is in the product, that it was made safely, and that it is legal to sell in a given market. For a brand, it is what turns a manufactured product into one that retailers will stock, customs will clear, and marketplaces will list.
As a full-service dietary supplement contract manufacturer, we issue this paperwork for every product we make — some per batch, some per formula. The four documents below are the ones brands ask for most. Each is summarized here; follow the link in any section for the full detail.
Certificate of Analysis (COA)
The most-requested document in the supplement industry. A COA is a batch-specific laboratory report confirming a finished product meets its specification — its identity, potency, and purity. We issue one for every batch we produce, in line with our GMP and FDA obligations, so retailers, importers, and marketplaces can verify a product before it ships.
Certificate of Free Sale (CFS)
Think of it as an export passport. A CFS certifies that a product is legally and freely sold in the United States — proof that many countries require before they will register an imported supplement or release it through customs. We help arrange it through the appropriate authority for your destination market.
Certificate of Composition
Where a COA proves quality, a Certificate of Composition proves content — the complete formula, ingredient by ingredient, with quantities. Customs authorities rely on it to clear imports, and it is equally useful for ingredient or allergen verification. Because it describes the recipe rather than a single run, we issue it per product.
How composition certificates work
Amazon Compliance
Not a single certificate, but a packet. Amazon enforces supplement-specific rules and asks for documentation to approve, ungate, or audit a listing — typically a COA, facility GMP/FDA proof, a compliant label image, and an ingredient statement. We compile it from your QC and facility records so a listing gets approved and stays live.
Documents at a Glance
| Document | What it proves | Primary use case | Issued per |
|---|---|---|---|
| Certificate of Analysis | Batch meets identity, potency & purity specs | Retail/Amazon onboarding, import, QA | Batch |
| Certificate of Free Sale | Product is legally sold in the U.S. | Export / foreign registration | Request |
| Certificate of Composition | The exact, full formulation | Customs clearance, ingredient verification | Product |
| Amazon Compliance | Listing meets Amazon’s supplement policy | Listing approval, ungating, audits | Listing |
Not sure which documents your product needs? Our team will map it to your target retailers and markets — request a free quote or contact us. You can also browse our full certifications guide.
