The main market opportunity lies in the need for comprehensive GMP audits in the pharmaceutical industry. By integrating interviews with traditional methods, such audits provide deeper insights into ...

Advancing small molecules from R&D to GMP requires coordinated strategies to support phase I clinical manufacturing.

The main market opportunities lie in providing training for pharmaceutical professionals to enhance their internal GMP audit skills, ensuring compliance with regulatory standards and improving product ...

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for ...

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of ...

Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based ...

In this free webinar, gain insight into how integrated custom media development and manufacturing can reduce risk from non-GMP to GMP. Attendees will learn ways to align early prototyping with ...

FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act ...

MIAMI--(BUSINESS WIRE)--OrganaBio, LLC, announces initiation of GMP manufacturing operations at its new cell therapy manufacturing facility, launching a new paradigm in contract and development ...

Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...