Donat MgEST. 2014 · USA
A precise, contractual timing promise from Dr. Magdalena Donat's R&D bench to a retail-shippable batch. Five gated phases, instrument-grade verification, and ISO 22716 / cGMP compliance engineered into every hour — not bolted on at the end.
Each phase has a fixed deliverable, a fixed owner, and a fixed exit criterion. You do not advance to the next phase until the previous gate's spec sheet is signed.
90-minute consult with the head of R&D, ingredient sourcing through our 12-step library, label-claim review, and a signed formulation specification that freezes the active and excipient bill of materials.
Two 250-capsule bench runs on a manual capsule machine, screened by 11 PhD chemists and 4 registered dietitians. You receive a written sensory report covering dissolution, organoleptics, and label-claim feasibility.
Accelerated stability under ICH Q1A conditions, NIR spectroscopic potency verification on every batch, and a regulatory check of all structure/function claims against current FDA guidance. No shortcuts, no surprise rejections.
5,000-unit pilot on an automated encapsulation line with inline NIR verification, full GMP batch records, and a documented change-control log. The pilot run validates your process at production scale before the full run.
Full encapsulation run, label compliance review, retail-ready packaging on approved components, and a Certificate of Analysis for every SKU. Your first shippable batch leaves the floor on Day 14.
Two cGMP-certified facilities — 1420 Pierce Street, Linden NJ and a sister site in Reno NV — running eight encapsulation machines, four gummy depositors, and an inline NIR spectroscopic potency verifier on every production line. No upcharge, no batch reruns, no mystery about what is in the capsule.
Compliance is not a finish line — it is a designed-in property of every gate. Here is exactly where each certification earns its keep across the 14 days.
Phase 01 opens with a full production-spec document — premises, equipment, personnel, materials — reviewed against ISO 22716 §6 before raw materials are even ordered. Documentation is the first deliverable, not the last.
Each bench sample carries a cGMP-compliant batch record: weigh tickets, in-process checks, deviation handling, and signature trails. The same template scales from 500 capsules to 250,000 — no reformatting, no rework.
For Sport-certified SKUs, every raw material is screened against the NSF/ANSI 173 NSF Certified for Sport list, with chain-of-custody documentation filed before the stability clock starts. No retroactive compliance.
Organic-certified SKUs run on a dedicated, identity-preserved line with segregated storage and a separate CofA. Audit-ready at every shift change, not just at the annual inspection window.
Most founders walk in expecting an eight-month contract-manufacturing cycle. By the end of the first consult, we have usually collapsed that to 28 days from contract signing — and to a 14-day prototype-to-capsule runway once the spec sheet is signed. The trick is not magic. It is a frozen formulation, instrument-grade verification, and a compliance team that has already cleared 412 label reviews. The chemistry is straightforward when the process is engineered for it.
Ready to map your 14 days? The consult is 30 minutes, free, with the head of R&D.
Book a Free Formulation Consult