Regulatory Strategy for Clinical Trials in the European Union
Regulatory Strategy for Clinical Trials in the European Union: Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27...
Is it Time to Sharpen Your Target Product Profile (TPP)?
Is it Time to Sharpen Your Target Product Profile (TPP)? We’ve heard it countless times: “Fail early and live to fight another day.” “Preserve capital, human resources, and energy for a project with...
7 Benefits of Working with a Biostatistician
Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...
How to Select the “Right” CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
eQMS: Your Questions, Answered
If you work in a regulated industry, you’ve most likely heard the term eQMS or enterprise quality management system. But you may be wondering what is it? Why do I need it? And how do I choose the...
How to Adopt an eQMS in 3 Simple Steps
A recent survey showed that 33% of the organizations surveyed use paper quality management systems; 60% use some paper and some digital; and 7% use no QMS yet. (source: Gartner peer insights) Quality...
Understanding Bioequivalence and Product-Specific Guidances
The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most...
Meet the Expert: Daniel Solorio
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Critical Issues in Drug Development: Don't Get Derailed in Developmental Efforts
Pharmaceutical companies spend massive amounts of money on drug development. Regardless of a firm’s size, the investment is substantial; the smallest error can have catastrophic consequences,...
