simplify supplier assessments using Rx-360’s SAQ Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously […]

The increase in requirements and expectations from both Regulators and Customers has challenged the Pharmaceutical Industry to maintain sufficient oversite of their Supplier Management Programs. Suppliers as well are being asked to host more customer […]

As China continues to evolve its pharmaceutical regulatory landscape, organizations operating within or in partnership with the Chinese market must proactively adapt to remain compliant and competitive. The National Medical Products Administration (NMPA) has outlined […]

Get the tools you need for breaking down the barriers that hold the world back from optimal movement of critical goods and materials. Download the publication to access the video modules listed below that make […]

In a significant move to reshape its pharmaceutical landscape, China has unveiled a comprehensive guideline aimed at deepening the reform of drug and medical device regulation. Issued by the General Office of the State Council […]

In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for […]

The pharmaceutical landscape is evolving rapidly, and one of the most transformative shifts is the rise of direct-to-patient (D2P) distribution. As manufacturers seek to bypass traditional channels and deliver medications straight to patients’ doors, the […]

The purpose of this guide is to provide tools that enable suppliers and service providers of the Healthcare and Pharmaceutical Industry to carry out robust investigations of nonconformities that help determine the impact on the quality of the product involved and consequently, the potential adverse impact for the patient that uses that regulated product. This publication is available in three languages.

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply chain. Especially in regulated environments, QAs form a crucial part of the supplier qualification process. […]