Our five-stage process.

A single coordinated case, from first inquiry to the first follow-up cycle after the patient has received the therapy, moves through five stages. Each stage has its own review standard and its own deliverables, and each stage closes with a clear handoff to the next. This page describes the arc; the five linked pages below describe each stage in detail.

Stage one: inquiry

The first stage is a written intake. A prescriber, a family member, or an institutional partner describes the case, identifies the destination, and attaches what the treating physician has already written. Our case-intake team confirms receipt within one business hour and returns an initial feasibility signal within one business day. This stage is where most early declines happen; we try to identify unworkable cases at the front door rather than at paperwork. See Step 1: Inquiry.

Stage two: clinical review

Once the case passes intake, our AI Clinical Review Agent performs a structured review of the therapy choice against the current FDA label, the published evidence, and the patient-specific facts in the record. The Agent's output is reviewed by a human US-licensed pharmacist; where the therapy or the fact pattern warrants, the case escalates to a physician on our panel for further review. The stage closes with a clinical eligibility determination. See Step 2: Clinical review.

Stage three: regulatory review

In parallel with or immediately after clinical review, our AI Regulatory Review Agent assesses the named-patient pathway available in the destination country for the specific drug-indication combination, identifies the required documentation, and prepares the paperwork package the destination regulator will expect. Where jurisdictional ambiguity exists, a human regulatory advisor signs off. This stage closes with a regulatory feasibility determination and a ready-to-file documentation set. See Step 3: Regulatory review.

Stage four: sourcing and logistics

With clinical and regulatory determinations in hand, our case-coordination team places the order through our DSCSA-compliant specialty wholesale channel, stages the unit at Altima Care for dispensing, coordinates the cold-chain logistics to destination, and arranges customs clearance through a licensed broker at destination. The pharmacist-in-charge at Altima Care performs the prescription review and approves dispensing. See Step 4: Sourcing and logistics.

Stage five: delivery and follow-up

The therapy is delivered to the prescriber's specified receiving point, and chain-of-custody is reconciled before administration. After administration, we remain engaged for the first follow-up cycle: we confirm the patient tolerated the therapy, we coordinate the next dose or next cycle with the treating prescriber, and we route any adverse event reports through our pharmacovigilance channel. See Step 5: Delivery and follow-up.

Typical timelines

A straightforward specialty case from intake to delivery typically moves in two to four weeks. Cases involving ultra-cold or cryogenic logistics, or destinations with longer regulatory timelines, can extend to six to ten weeks. Cases requiring a new named-patient application in a destination that has not previously imported the specific drug can take longer still, and we will tell a family that at intake. What we do not do is quote a best-case timeline and then slide; our stated window is the window we expect to deliver inside of, and if the window slips we communicate it immediately.

What changes when a case is enterprise-managed

For hospital systems, specialty clinics, and payer networks that operate under a master services agreement with us, the five stages remain the same but the handoffs are pre-built into shared workflows. Documentation templates are pre-approved, the receiving institution's SOP is already on file, and the coordination fee structure is pre-negotiated. See enterprise and institutional partnerships for how that works.

Reviewed 2026-04-22 by Reserve Meds’s AI clinical and regulatory review agents. Human pharmacist-in-charge: Altima Care. Next scheduled review: 2026-10-22.