What we can evidence, and what we cannot. Both, in writing.
Every competitor page in this industry is a wall of certification logos. We are a new company and we do not have them yet. So instead of implying, here is how we operate, what the law actually requires of us, and what we are working toward and in what order.
Certifications: none yet, and we will not imply otherwise
We hold no third-party quality certifications at this time. We will not use the phrases "GDP certified", "cGMP facility", "FDA approved", "21 CFR Part 11 certified" or "IATA certified", because the first three describe things that either do not exist in the United States or would be a federal misbranding issue, and the last two describe a person’s training or a regulation you comply with — not a badge a company holds. When we earn something, we will publish the certificate number, the registrar and the expiry date, so you can verify it rather than take our word.
The roadmap, in the order we intend to take it
ISO 9001
A generic quality management system, and the foundation everything else sits on. Achievable in months rather than years for an operation our size.
HDA GDP Accreditation
The only legitimate US pathway to a defensible GDP claim — there is no US government GDP certification. Requires at least two people to complete all three HDA training levels before assessment. Valid two years.
IATA CEIV Pharma
Two staff pass the audit, quality and risk management assessment, then a three-to-four day on-site assessment. Notably, none of the major specialty couriers claim it on their own certification pages.
ISO 13485
Medical device quality management, covering production, storage and distribution. A commercial differentiator rather than a legal requirement for a distributor.
What the law requires of us regardless
Some obligations are not optional and not marketing. Anyone who packages, labels or offers dry ice or UN3373 for transport is a hazmat employee under 49 CFR 172.704 and must hold general awareness, function-specific, and safety and security awareness training, recurrent at least every three years. Offering dangerous goods by air requires competency-based training and assessment under the IATA Dangerous Goods Regulations, recurrent every 24 months. These are conditions of doing the work, not credentials to boast about.
Operating procedures
- Written procedures for receipt, put-away, storage, picking, packing, shipping and destruction
- Continuous electronic temperature monitoring with per-tier alarm thresholds
- Documented excursion procedure: record, notify, quarantine, await your disposition decision
- Chain of custody recorded at every transfer of responsibility
- Lot and expiry captured at receipt and carried through every movement
- Segregated quarantine, on-hold and released stock
- Controlled artwork with attributable, version-specific, retrievable approvals
- Job-by-job reconciliation on labeling and kitting runs
- Documented destruction and disposition
Scope limits we hold to
- We do not handle human prescription drugs, which carry separate state licensure and federal reporting obligations
- We do not relabel finished human drug or device products, which can trigger FDA establishment registration as a relabeler
- We do not ship Category A infectious substances under UN2814 or UN2900
- We are a logistics provider, not a laboratory — we do not test, and we hold no CAP or CLIA credentials because they would not apply to us
Tell us what you need to move, and at what temperature.
Send us the materials, the temperatures and the destinations. We will come back with a scope and a price — not a discovery call.