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.

  • Current FDA facility registration, confirmed directly
  • Inspection history and enforcement record reviewed
  • GMP-aligned quality systems assessed before onboarding
  • Ongoing monitoring — not a one-time checkbox
Racked warehouse storage for organized inventory placement and retrieval
Racked, organized storage at our Hillsborough, NJ facility.

Testing & documentation

Every lot arrives with its paperwork.

A certificate of analysis accompanies every lot we supply — no exceptions, no "available on request."

Certificates of analysis

Lot-specific COAs documenting identity and purity testing accompany every shipment, so your records are complete the day material arrives.

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.

Temperature-controlled cold room shelving for products requiring cold storage
Cold room — 2–8°C documented storage.

Chain of custody

Documented handling from receipt to your dock.

Material moves through our partner's pharmaceutical distribution operation under documented conditions: controlled receiving, condition-appropriate storage — ambient or cold chain (2–8°C) as each material requires — and shipment records that close the loop.

  • Documented receiving and inspection on intake
  • Condition-appropriate, monitored storage
  • Cold-chain shipping with temperature documentation where required
  • Complete custody records available to buyers

The 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 is what 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.

Right-channel sales only

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.

No 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.

No 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.

Reach out and ask us the hard questions — sourcing, testing, custody, channels. We built this company to answer them.