As pharma shifts from synthetic molecules to biologics and proteins, temperature maintenance has become as important as the drug itself. GNH USA's cold-chain process is validated under WHO GDP guidelines — best-in-industry for shipments worldwide.
According to WHO Good Distribution Practices, certain medicines must be manufactured, transported and stored at very specific temperatures. Cold-chain is therefore a supply-chain management process covering storage and transport of temperature-sensitive goods — vaccines, serums, biologicals, test samples — from manufacture to use, using thermal and refrigerated packaging methods.
Validated boxes
Our validated shipping system
In-transit monitoring
Temperature monitored en-route with data loggers
FAQ
Frequently asked questions
What is a validated cold chain?
A validated cold chain is a temperature-controlled supply chain whose packaging and process have been formally qualified to keep medicines within a required temperature range from manufacture to use. GNH USA's process is validated under WHO GDP guidelines.
Which products need cold-chain shipping?
Vaccines, serums, biologics, proteins, test samples and other temperature-sensitive medicines require cold-chain handling.
How do you prove the temperature was maintained in transit?
Temperature data loggers can be added to shipments for continuous in-transit monitoring and post-delivery review, and a validation report and certificate of analysis for the box are kept on file.
Where do your validated boxes come from?
The validated shipping boxes are mainly imported from the UK or Germany and are conditioned before use as per the manufacturer's instructions.
Can you ship temperature-sensitive medicines worldwide?
Yes. GNH USA ships cold-chain consignments worldwide under WHO GDP-validated processes.
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End-to-end IMP sourcing, kitting and depot-to-site logistics — GDP-compliant warehousing, manufacturer relationships and a full source-to-site audit trail.
Comparator Sourcing for Clinical Trials
Reference-listed drug and active comparator supply for clinical trials worldwide — direct from manufacturer, with WHO GDP-compliant logistics.
Dossiers and Stability Studies
Stability and BA/BE studies for pharmaceuticals and biologicals, plus eCTD dossier preparation for US, EU and other regulated and emerging markets worldwide.