and ensuring data integrity throughout the drug development lifecycle and beyond. In fact, there is AI software dedicated specifically to analysing regulatory requirements and helping ...

CDSCO seeks urgent industry inputs on regulatory challenges and innovation in pharma: Shardul Nautiyal, Mumbai Thursday, January 23, 2025, 08:00 Hrs [IST] The Central Drugs Standa ...

Regulatory complexity isn’t the only challenges clinical services organizations face in the APAC market. Cheong points to ...

“Combining the three organizations at Genzyme is a strategic move in line with the external environment where we see ever more convergence between the requirements of regulatory ...

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial ...

In this article, I break the development life cycle into actionable stages, providing insights into creating robust, ...

There also appears to be a paradox in regulatory standards for cancer therapies, which may inadvertently create a seemingly irrational approach to drug development and contribute to the high ...

These initiatives represent a way to accelerate access to treatments that have historically faced longer regulatory pathways.

In this episode, Simina Petrovan explores the roles and responsibilities of upstream process development in bringing novel and innovative molecules to market, providing a comprehensive look at its ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...