What is Real-Time Release Testing? Real-Time Release Testing (RTRT) is an advanced approach to biopharmaceutical manufacturing quality control that improves upon current systems. RTRT is defined as ...

SGS, the world’s leading testing, inspection and certification company, has expanded its analytical capabilities for the Chinese pharmaceutical industry with the introduction of nuclear magnetic ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...

Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and designing FDA-compliant stability programs ...

Pharmaceuticals are developed, designed, and commonly manufactured in laboratory settings. Laboratory testing is an essential need in almost every stage of pharmaceutical production and R&D, from the ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

As a central pillar of modern society, the pharmaceutical industry bears the load of billions of lives around the world. In 2022, the global revenue of the pharmaceutical industry approximated $1.5 ...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical ...

The OIG concluded that the requestor’s arrangement implicates the Anti-Kickback Statute (AKS) because it results in remuneration to patients and health care professionals that may induce the purchase ...