Your broker should know
21 CFR Part 211 better
than your QA team.
Clearance moves temperature-sensitive biologics, monoclonal antibodies, and small molecules across U.S. borders — navigating FDA holds, cold chain documentation, and import alerts so your shipment arrives with potency intact and paperwork bulletproof.
Every biologic shipment we handle travels through a documented cold chain protocol — from GMP lot release at origin through FDA-supervised port entry to 3PL handoff. Temperature excursions trigger immediate deviation reports, not silence.
GMP lot release, CoA verification, qualified person sign-off
IoT data loggers, IATA P650 compliance, dry ice management
ISF 10+2, ACE entry, FDA Prior Notice — filed 24h pre-arrival
PARS pre-screening, temperature log submission, hold resolution
Notice of FDA Action, chain of custody transfer, 3PL handoff
Full serialization and traceability requirements met for all prescription drug imports. Non-compliant shipments face up to $500,000 in FDA fines — we handle this before the shipment leaves origin.
Most brokers treat FDA compliance as a checkbox. We treat it as an engineering problem with a documented solution for every failure mode — from prior notice rejection to Schedule II controlled substance import authorization.
FDA Prior Notice Automation
AI-powered submission engine files Prior Notice of Imported Food and Drug entries 24 hours pre-arrival, integrating directly with FDA systems for real-time validation. Zero manual transcription errors.
- PNSI (Prior Notice System Interface) direct integration
- Automatic PN number generation and tracking
- Real-time FDA acknowledgment confirmation
- Rejection alerts with corrective action in < 15 minutes
Industry average: 28–72 hours. Our 11.4-hour average is the result of pre-filing automation, prior notice submission at origin, and ACE integration that routes entries through automated selectivity before your cargo lands.
Entry summary, commercial invoice, and packing list uploaded to ACE 48h before estimated arrival. CBP targeting algorithms process before wheels down.
Automated PNSI submission eliminates manual filing delays. Real-time FDA acknowledgment received within 90 seconds of submission.
ISF filed 72h pre-vessel departure — not at arrival. Prevents holds triggered by late ISF penalties and CBP exam queuing.
Direct ACE system integration routes entries through automated selectivity. Manual intervention only when CBP exam is mandated.
A $2M biologic sitting on a tarmac with no status update is not an acceptable situation. Our visibility platform gives supply chain directors, regulatory affairs managers, and 3PL coordinators the same real-time data our operations team sees.
Live ACE entry number tracking with ITACS integration — view Notice of FDA Action the moment it's issued, not when your broker remembers to check.
5-minute interval data logger readings streamed to your dashboard. Any excursion above ±0.5°C triggers an immediate deviation report and corrective action protocol.
Every entry document — commercial invoice, packing list, CoA, temperature logs, FDA NOA — indexed and searchable. Audit-ready within 15 minutes of any FDA request.
Managing simultaneous entries at Newark, Long Beach, and Miami? Single dashboard view with port-specific status, exam queues, and estimated release times.
All FDA status data sourced directly from ITACS (itacs.fda.gov) — the FDA's official Import Trade Auxiliary Communication System. No third-party intermediary.
A generic freight broker can file a commercial invoice. They cannot resolve an IA 66-40 import alert, manage a cold chain deviation report, or know that a Type II DMF reference authorization is needed before your API shipment clears.
Request a Clearance Audit
Tell us your product type, primary port, and current broker. We'll identify the three most likely compliance gaps in your current import process — within 48 hours.
Download Our FDA Hold Resolution Playbook
A step-by-step protocol for resolving FDA import holds — covering Import Alert types, Voluntary Admissibility Requests, temperature excursion documentation, and field office escalation. Used by our team on every hold we resolve.