Transportation, lane, packaging and cold chain advisory, led by the people who wrote the standards.
Transportation validation strategy, best-practice roadmaps, embedded SME support. An independent read of your cold chain before money is committed. We review how you qualify lanes, who owns the evidence, and where the program would fail an audit, then give you a sequenced roadmap with named owners.
Defines what must be proven, for which lanes and configurations, and to what acceptance criteria. Ends with an approvable strategy and a remediation plan.
Produces the evidence against that definition: master plan, thermal assessments, simulation, qualification protocols and reports.
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.
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.
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.
Transportation validation strategy, BLA content and IR responses, lane qualification, thermal test design, ICH Q9(R1) risk review, network optimization.
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.
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.
#20YearsInTheCold · Empowering Cold Chainge