Certificates of analysis
Lot-specific COAs documenting identity and purity testing accompany every shipment, so your records are complete the day material arrives.
Quality & compliance
Documentation is the product.
Anyone can ship a vial. What our buyers actually get is certainty: a vetted source, a tested lot, a documented chain of custody, and a supplier who verifies who they sell to.
Sourcing standards
Only FDA-registered manufacturers — vetted, then re-vetted.
Every ingredient in our catalogue traces to a manufacturer holding a current FDA facility registration. Before onboarding a source, we review its registration status, its inspection and enforcement history, and the maturity of its quality systems.
Sources are reviewed on an ongoing basis, and any change in regulatory standing triggers immediate re-evaluation.
01
Current FDA facility registration, confirmed directly
02
Inspection history and enforcement record reviewed
03
GMP-aligned quality systems assessed before onboarding
04
Ongoing monitoring — not a one-time checkbox
Testing & documentation
Every lot arrives with its paperwork.
A certificate of analysis accompanies every lot we supply — no exceptions, no “available on request.”
Independent verification
Supporting analytical documentation and independent third-party testing arrangements are available on request for buyers whose programs require them.
Lot traceability
Every unit is traceable to its manufacturing lot, and every lot to its source facility — recall-ready record keeping as standard practice.
Chain of custody
Documented handling from receipt to your dock.
Material moves through our partner’s pharmaceutical distribution operation under documented conditions — ambient or cold chain (2–8°C) as each material requires — with shipment records that close the loop.
Cold room — 2–8°C documented storage
Racked storage in Hillsborough, NJThe right channel
Every order through the right channel.
Licensed purchasers buy from us directly; clinics and practices are served through our licensed pharmacy partners. Matching every buyer to the right channel keeps the whole chain trustworthy.
Who buys direct
- State-licensed 503A compounding pharmacies
- FDA-registered 503B outsourcing facilities
- Licensed drug manufacturers
- Qualified institutional buyers
How we qualify
- Business identity and, where applicable, licensure
- The right channel for each inquiry
- Fit between the order and the buyer
Where we draw the line
- No product sales to individuals
- No sales outside the licensed channel
- No orders that do not fit the buyer
Drawing the line
What we deliberately don’t do.
Trust is easier to demonstrate by what a company refuses than by what it promises.
Sell outside the right channel
Product sales go to licensed and qualified purchasers, as the law requires — everyone else is welcome to reach out and gets routed to a licensed partner who can serve them.
Make medical claims
We make no claims about the safety, efficacy or clinical use of any compound. Clinical decisions belong to licensed practitioners and regulators — not ingredient suppliers.
Ship undocumented product
If a lot cannot ship with a certificate of analysis and full traceability, it does not ship. There is no expedited path around documentation.
Hold us to this standard.
Ask us the hard questions — sourcing, testing, custody, channels. We built this company to answer them.