Twenty years
in the cold.
Empowering Cold Chainge
Tell us where the cold chain is uncertain and we will tell you what it would take to make it defensible: strategy, evidence and the answer at the filing.
There is a person at the end of every shipment, waiting for something they cannot live without.Twenty years on, that is still the only reason any of this matters.
— Carli Derifield, Founder
Every link in the cold chain.
Strategy & Advisory
Transportation validation strategy, best-practice roadmaps, embedded SME support.
Regulatory & BLA
BLA transportation content, information-request responses, CAPA and audit resolution.
Lane Qualification
Lane and mode qualification, route and SLA validation, PQ ship studies.
Lane Mapping & ATP
Lane mapping studies, ambient temperature profiles, simulation and forecasting.
Qualification Testing
Thermal DQ/OQ, distribution hazard testing, shipper and facility mapping.
Quality Risk Review
Qualification package review, ICH Q9(R1) risk assessment, gap closure.
Network Optimization
Site, lane and packaging audits, SKU rationalization, supplier RFI and RFP.
Coaching & Augmentation
Training your team, temporary cold chain capacity, an expert on call.
Strategy, Execution and Defense. One owner.
Strategy
Defines what must be proven, for which lanes and configurations, and to what acceptance criteria. Ends with an approvable strategy and a remediation plan.
Execution
Produces the evidence against that definition: master plan, thermal assessments, simulation, qualification protocols and reports.
Defense
Carries the package into the submission and stands behind it: summary report, CTD content, agency responses and inspection readiness.
Every handoff between these is where misinterpretation enters, and that risk lands on the sponsor, at the filing. We will take one phase or all three, but we will always tell you which structure protects you.
Every thermal system, ambient to cryogenic.
CRT product, apheresis collection and ancillary material. Short, time-critical lanes where dwell and tarmac exposure do the damage.
Biologics, vaccines, LNP drug product, drug substance and critical raw materials on dry ice, with sublimation and dangerous-goods controls.
Cell and gene therapy finished product in LN2, with depot storage, chain of identity and lot-to-patient custody carried end to end.
Every thermal system, parcel to pallet and truck.
3 pandemics. 2 disasters. 1 answer.
Not once did we fail. Because the person at the end of the cold chain was waiting for something they could not live without.
We do not sell packaging. We do not take referral fees.
A validation strategy written by a party with a commercial interest in the equipment under assessment invites an avoidable question during inspection. Independence removes the question entirely.
No ownership, affiliation, referral arrangement or revenue relationship with any shipper manufacturer, packaging supplier, courier, 3PL or depot operator in your network.
Laboratory costs are quoted to you directly and carry no mark-up, so the volume of testing we specify is never a revenue lever for us.
Vendor qualification data is assessed on its merits and escalated where it falls short, without us sitting on both sides of that assessment.
Change shipper, pack-out or 3PL before launch and the qualification framework survives it, rather than needing to be rebuilt around a new vendor.
Carli Derifield, Founder & SME Consultant
Twenty years across cold chain, quality and regulatory, on the buy side and the build side. Third cold chain company, after building and exiting two packaging companies.
First to own and operate an ISTA-certified thermal testing laboratory. Funded and authored the first ISTA Standards 20, 14 and 7E. Expert author on the Pharma.Aero PQI paper on supplier qualification.
Called in for H1N1, Ebola, Hurricane Maria, COVID-19 and Hurricane Ida.
The person who writes your strategy is the person who executes it, answers the agency's questions about it, and is in the building for the inspection. No account manager. No hand-off to a junior team after the sale.
A team of 60+ independent SMEs. One contract.
Cold Chain Consult
Transportation validation strategy, BLA content and IR responses, lane qualification, thermal test design, ICH Q9(R1) risk review, network optimization.
TEN-E
Thermal and cold chain (ISTA 7D, 7E), insulated shipper validation, distribution and hazard testing, dangerous goods. ISO/IEC 17025 accredited.
Two privately owned and operated firms. Roughly 60 subject matter experts, one team, one contract: a single vendor approval instead of two, and no investor-backed parent setting the methods.
Trusted from start-up biotech to global pharma.
Sponsors, CDMOs, couriers, depots and standards bodies, and, as often as not, both sides of the same lane. And more.
When it cannot fail.
Tell us where the cold chain is uncertain and we will tell you what it would take to make it defensible: strategy, evidence and the answer at the filing.
carli@coldchainconsult.com
+1 714 262 6955
Newport Beach, CA 92663
Newport Beach · Global
#20YearsInTheCold · Empowering Cold Chainge