Clinical Research Solutions
How to Prepare for Laboratory Partner Selection during CBD Product Development
The interest in developing consumer products or therapies derived from Cannabis or CBD is continuously growing. As these new products come to market, there is increasing need to comply with...
Clinical Research Solutions
How Many Observations are Hiding in Your Quality System?
Reflecting on 2020, we have become accustomed to the global shift into a world of virtual, remote, restricted, and paused. One no longer flinches when hearing that something has been modified,...
Clinical Research Solutions
Meet the Expert: Simona Mills, PMP
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Clinical Research Solutions
Biosimilars: How the Approval Process Differs from a Standard ANDA
Biosimilars, by their very nature, are different from generic drugs. The core difference is that generic drugs are chemically synthesized, while biosimilars are grown in complex living systems....
Clinical Research Solutions
EMA vs. FDA Virtual GCP Auditing Guidance: What You Need to Know
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
505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway
Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug...
Clinical Research Solutions
What You Need to Know About the ICH
The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices....
Clinical Research Solutions
Virtual GCP Auditing: Your Questions Answered!
How quickly the auditing landscape has changed! Less than one year ago if ProPharma Group were asked to perform a clinical audit on your firm’s behalf, we would reply with “when, what, and where?”...
Clinical Research Solutions
Key Takeaways: New Draft Guidance on Cannabis and Clinical Research
On July 21st, 2020, the FDA released a draft guidance document for developers of cannabis and cannabis derived compounds, aptly titled “Cannabis and Cannabis Derived Compounds: Quality Considerations...
Clinical Research Solutions
6 Quick Tips for Excel Spreadsheet Validation
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...