Cold-chain excursions, DSCSA serialization gaps, customs holds on cell & gene shipments, and clinical-trial site delays don’t just damage product — they damage patient outcomes and trial timelines. Generic 3PL is the wrong answer. A purpose-built GxP operating discipline, integrated with our specialty pharmacy portfolio (MintRX), is the right one.
Every line is delivered under one GxP operating standard — one SOP library, one CAPA system, one validated TMS, one audit trail. Bundling is the value; QA fragmentation is the risk.
Validated multi-zone storage for finished drug product, biologics, vaccines, diagnostics, and specialty therapeutics. Built around the WHO and EU GDP framework and aligned with US 21 CFR Part 211 and DEA controlled-substance handling where applicable.
Temperature-controlled trucking, air, and ocean lanes operated against qualified packaging, monitored loggers, and a stability-budget framework that protects product integrity from origin dock to patient-side delivery.
Full electronic interoperable EPCIS-based exchange of transaction information across the supply chain — the regulatory backbone the FDA enforced fully on November 27, 2024. RK ingests, persists, and forwards serialized data without breaking the chain.
Investigational product (IP) storage, site kitting, blinded labeling, and direct-to-site distribution coordinated with sponsor IRT systems and the protocol’s randomization plan. Returns and destruction handled within the same audit envelope.
For autologous CAR-T, allogeneic cell therapies, gene therapies, and rare-disease therapeutics where every shipment is a single patient’s treatment window — a different operating tempo than commercial-scale pharma. We pair MintRX patient-direct expertise with chain-of-custody discipline borrowed from our white-glove GPU work.
A customer-facing visibility and coordination layer tuned to GxP. Real-time temperature, location, and chain-of-custody, plus predictive alerts on excursion risk, DSCSA exceptions, and at-risk clinical-trial site deliveries.
After multiple delays, the FDA’s Drug Supply Chain Security Act reached full electronic interoperable enforcement on November 27, 2024. Wholesalers and dispensers can no longer accept saleable returns — or unverified inbound — without a clean EPCIS chain. Every gap is a stockout risk and an audit liability. RK’s platform is DSCSA-aware end to end and was built for this regime, not retrofitted to it.
Roughly 60% of US prescription approvals now require active temperature control, and a growing share require ultra-cold (–80°C) or cryogenic (LN₂) handling. Cold-chain excursions cost the industry north of $35B per year in product loss, recalls, and trial delays — most of them preventable with validated packaging, continuous monitoring, and pre-defined excursion protocols. RK runs to that standard by default.
An autologous CAR-T shipment isn’t a freight bill — it’s one patient’s only dose. Apheresis collection in Houston, manufacturing in New Jersey, infusion-center delivery in Phoenix, cryogenic preservation throughout, chain-of-identity verified at every hop. RK runs this as a project, with the same discipline we apply to white-glove AI servers — but on a GxP quality system.
Patient-direct dispensing models — limited-distribution drug channels, hub services, copay and prior-auth workflows — are pulling specialty pharmacy operations directly into the manufacturer’s commercial plan. RK is uniquely positioned via MintRX, our specialty pharmacy operation, to deliver cold-chain logistics and patient-direct dispensing as one continuous service line.
We work with pharmaceutical manufacturers, CDMOs, biotech innovators, clinical research organizations, and the wholesalers and specialty pharmacies they ship through — bringing GxP logistics discipline to portfolios that range from generic tablets to autologous cell therapies.
Commercial-scale finished-goods distribution, controlled-substance handling, and DSCSA-compliant serialized lanes — coordinated with your wholesaler partners and 340B channels under one operating standard.
From early clinical supply through commercial launch — storage, kitting, distribution, and cold-chain validation that scale with your portfolio. RK runs in weeks, not quarters, when your launch window slips earlier.
IP storage, site kitting, blinded labeling, direct-to-site and direct-to-patient distribution, returns and destruction — all coordinated with your IRT/RTSM and sponsor QA system inside one audit envelope.
Cryogenic shipping, chain-of-identity discipline, hub-services integration, and patient-direct dispensing via the MintRX network. RK runs the operation; you protect the patient timeline.
Active life-sciences operations across the highest-density pharma corridors in North America, anchored by RK warehouse capacity, the MintRX specialty pharmacy network, and validated cross-border lanes into Canada.
The center of US pharmaceutical manufacturing. RK warehouse capability tied into the MintRX specialty network, with proximity to major pharma campuses and the FDA Mid-Atlantic district.
Project-by-project deployment for early clinical-stage biotech and cell & gene therapy innovators in Kendall Square and the broader Route 128 belt.
CDMO and gene-therapy cluster coverage from Durham through Research Triangle Park — cold-chain transport lanes into both Atlanta and Mid-Atlantic distribution hubs.
RK’s Fremont and Bay Area footprint extended into the SSF biotech corridor — cold-chain transport into Genentech / Vacaville and the broader Northern California biotech belt.
Southern California biotech and diagnostics capability. Direct lanes from San Diego to LA-area cold-chain hubs and the Port of Los Angeles for international inbound.
Growing CDMO and specialty-pharmacy corridor. RK warehouse and last-mile capability across the Chandler / Mesa / Gilbert / Pinal County footprint.
Validated air-freight lanes anchored to the FedEx Memphis SuperHub and the Indianapolis FedEx Cargo hub — the backbone of overnight specialty distribution.
Cross-border life-sciences logistics with US-Canada customs brokerage handled inside the same CargoWise platform — no handoff to a third party at the border.
Running on CargoWise, layered with an EPCIS data lake and an excursion-prediction model. Built so the QA lead reviewing audit data sees the same picture as the trial monitor watching site deliveries.
Continuous temperature, humidity, GPS, and chain-of-custody data unified per SKU and per lot — not per freight bill. One audit-ready record per patient’s dose.
An AI layer trained on packaging stability budgets, weather, and lane history surfaces probable excursions 4–24 hours before they breach spec — with a recommended packaging or routing action attached.
EPCIS gaps, ATP failures, and suspect-product workflows surfaced to QA in real time — not discovered during the next audit. Saleable-returns verification integrated.
SOPs, batch records, certificates of analysis, deviation reports, CAPAs, and EPCIS data — one searchable record per lot, audit-ready for FDA, DEA, and customer QA.
Most life-sciences logistics partners assemble a program through subcontractors. Coordination overhead — and quality-system gaps when things go wrong — is the result. RK runs the chain end-to-end inside one GxP operation, on one platform of record, with the MintRX specialty pharmacy network on the dispensing end.
Ocean and air freight, US and Canadian customs brokerage, classified through the same CargoWise platform that runs the rest of the program. Drug-product imports clear customs without losing temperature visibility.
Validated lanes with packaging stability budgets per SKU, active reefer trailers, passive PCM and dry-ice shippers, and a specialty courier network for clinical-trial and cell & gene shipments.
Validated multi-zone storage, DSCSA-aware EPCIS exchange, and a quality system that survives an unannounced FDA inspection. Bonded storage for imports pending release.
RK’s specialty pharmacy operation closes the loop — limited-distribution-drug channels, hub services, copay and prior-auth workflows, and cold-chain patient-direct dispensing inside the same audit envelope.
In life sciences, the freight bill is the smallest cost in the room. The patient’s timeline is the largest.
The earlier RK is in the program — ideally before cold-chain packaging is locked — the more launch risk we can absorb. Send us your therapeutic profile and target commercial launch date. We’ll map the GxP logistics critical path and come back with a quality-systems plan.