Clinical trials are undergoing a fundamental shift as emerging technologies reshape how studies are designed, executed and ...

Regulatory planning and development assessment encompass a coordinated suite of methodologies aimed at evaluating the impact, efficiency and equity of planning policies and regulatory interventions.

The pharmaceutical sector is experiencing growth through market expansion and global collaboration. To encourage this growth, compliance with regulations in Chemistry, Manufacturing, and Controls (CMC ...

• Global regulatory harmonization would lower barriers for drug developers, but payers and, in many countries, health technology assessment bodies still determine if a drug that makes it to the market ...

Veristat (the “Company”), a science-first full-service CRO and consultancy that advances complex therapies through the drug development lifecycle to regulatory submission, announced today its intended ...

Launching in 2025, the European Platform for Regulatory Science Research will bring together academia, regulators and other stakeholders to accelerate collaborative regulatory science research ...

You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most expeditious and risk ...

In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission ...

Agile PLM supports continuous improvement, enhances visibility across the product lifecycle, and reduces the risk of costly errors. As a result, it is becoming a cornerstone of modern medical device ...

Following a year of profound geopolitical instability, continued technological disruption, and global economic stress, the Gulf region is strategically using regulatory reform to bolster its presence ...

As electrification in the automotive industry becomes standard and the roll-out of software-defined vehicles (SDVs) gains extra mileage, technology complexity is becoming a key issue for the industry, ...