When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.

Regulatory approval is a major milestone in the drug development process, but it is not the final chapter in the journey.

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal ...

Biosimilar formulation development requires navigating around scientific, regulatory, and legal challenges, according to Sung ...

CHARLOTTETOWN, Prince Edward Island--(BUSINESS WIRE)--Today BIOVECTRA celebrates the completion of its $90 million plus biologics expansion at the company’s new state-of-the-art Biomanufacturing ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...