PDURS: The time 
is now to digitize
 your drug pipeline.
Prescription Drug Use-Related Software (PDURS) is designed to support, improve, or supplement the use of prescription medication. Thanks to the FDA’s PDURS framework, digital solutions can now be clinical components that live in your drug’s label.


At Amalgam, we’re building PDURS for our Pharma partners and helping them navigate this new regulatory frontier.
Let us help you achieve FDA labeling that differentiates your brand and improves patient outcomes.
PDURS: The time 
is now to digitize
 your drug pipeline.
Prescription Drug Use-Related Software (PDURS) is designed to support, improve, or supplement the use of prescription medication. Thanks to the FDA’s PDURS framework, digital solutions can now be clinical components that live in your drug’s label.


At Amalgam, we’re building PDURS for our Pharma partners and helping them navigate this new regulatory frontier.
Let us help you achieve FDA labeling that differentiates your brand and improves patient outcomes.
Is your brand a candidate for PDURS?
Build an enhanced
therapy asset.
The window to lead the market with the first generation of PDURS-labeled therapies has opened. Whether you are launching a new therapy or defending a legacy brand, Amalgam provides the platform, regulatory expertise, and Medical-Grade AIâ„¢ to turn your digital companion into a clinical asset.
A Credible Partner for Regulatory Success
Enhance Patient Impact with
Medical-Grade AIâ„¢
Medical-Grade AIâ„¢ built for FDA success
Our platform combines rigorous clinical logic with high-engagement AI to prove the safety and efficacy your labeling demands.
Total Connectivity 
from Patient App to EHR Workflow.
Let’s audit your portfolio and
map your evidence strategy
Is your brand a candidate for PDURS?
Build an enhanced
therapy asset.
The window to lead the market with the first generation of PDURS-labeled therapies has opened. Whether you are launching a new therapy or defending a legacy brand, Amalgam provides the platform, regulatory expertise, and Medical-Grade AIâ„¢ to turn your digital companion into a clinical asset.
A Credible Partner for Regulatory Success
Enhance Patient Impact with
Medical-Grade AIâ„¢
Medical-Grade AIâ„¢ built for FDA success
Our platform combines rigorous clinical logic with high-engagement AI to prove the safety and efficacy your labeling demands.
Total Connectivity 
from Patient App to EHR Workflow.
Let’s audit your portfolio and map your evidence strategy