Clinical Research Solutions
In response to the COVID-19 pandemic, global regulatory authorities adopted a pragmatic virtual auditing approach. This approach includes the flexibility and procedural simplifications to maintain...
Clinical Research Solutions
Are you using Microsoft Excel spreadsheets for GxP activities? Are these Excel sheets used again and again, as a template? Ever thought about validating your spreadsheet templates? Is the person who...
Clinical Research Solutions
Improve your R&D Strategy with These 6 Tips. In 2017, R&D investments in the pharmaceutical space reached more than $70 billion, with projected figures of over $200 billion by 2024. Pharma is one of...
Clinical Research Solutions
Big data is hitting us from all angles, and life science industries are not being left out. Why? Your life depends on it, literally. Life sciences generate lots of large and complex data every single...
Clinical Research Solutions
Using a Matrix Approach to Media Fills in Sterile Compounding: A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to...
Clinical Research Solutions
Critical Components of Quality Management Systems: In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP), which must be compliant...
Clinical Research Solutions
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Clinical Research Solutions
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...