How to Respond to Cold Chain Information Requests


The experts at Modality Solutions walk you through response techniques for Information Requests from the FDA on your cold chain. 

Watch our video to hear industry experts, Andrew Larrigan and Carson Dickey, give real cold chain IR examples and discuss accepted responses. Discover using Transport Simulation from the start can reduce potential IRs.


Historically, drug transport validation was conducted using real-life shipments in the field. But these shipments can’t duplicate the extreme, concurrent environmental hazards a drug product is likely to face in transit. As a result, real-world shipment data does not provide enough information.

The Transport Sim Lab is the only way to accurately gauge how your therapeutic and your pharmaceutical cold chain will interact under worst-case conditions. With advanced facilities and their multi-disciplinary engineering expertise, Modality Solutions gives you confidence in your drug stability.

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Related Resources


How to Successfully Respond to an FDA Information Request (IR)

You’ve submitted a new drug application (NDA) or a biologics license application (BLA) for your new drug candidate. Congratulations! It’s common for the FDA to issue an Information Request (IR) during its review cycle. When that happens, it’s critical that you respond quickly and effectively to get your vaccine or therapeutic approved in a timely way.


How to Avoid an FDA Form 483 or a Warning Letter for Your mAb or Other Biologic

When your mAb or other biologic is moving through the Biologics License Application (BLA) process, a pre-approval inspection (PAI) by the FDA is a critical step that can either facilitate or hamper your therapeutics approval. If the investigator finds practices or conditions that are considered objectionable or potentially violate agency regulations, you could be issued a Form 483 or a Warning Letter.