Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Creating a new drug involves significant time, effort, and resources. Many assume drug development is straightforward, with final products approved fairly quickly, but the drug approval timeline can ...

Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early ...

Dr. Olga Paley, Director of Bioprocess Development at Takeda, will discuss “Advancing Takeda’s Bioprocessing Platforms in Support of Clinical and Commercial Drug Supply” about the Chemistry, ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Pharmaceutical regulatory consulting for drug developers and CROs: IND CMC, method validation, NDA strategy, and FDA ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Practical guidance for sponsors to extract meaningful insight—and avoid costly surprises— when vetting CDMO partners.

Explore how contract development and manufacturing have transformed within the pharmaceutical industry, shaping current ...