Quality & Compliance
Key Challenges of CRISPR Drug Development Project Management
CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, is a gene-editing technology that holds enormous promise for treating genetic diseases. However, developing CRISPR-based drugs is...
Meet the Expert: Ana Ming
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...
Quality & Compliance
Key Challenges of Specialty Pharma Drug Development Project Management
Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...
Meet the Expert: Collin Freeman
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...
Meet the Expert: Tiffany Rice
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...
Meet the Expert: Alexis O'temro
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...
Meet the Expert: Dr. David Crome
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...
7 Considerations When Implementing and Maintaining a Research Data Management Platform
Investments in digital transformations are expected to grow from $594.5 billion USD in 2022 to $1.548.9 billion USD by 2027, with the goal of improving the generation, collation, storage, and...
Meet the Expert: Amy Scalise
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...
Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023
The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...
Quality & Compliance
The Importance of Responding to FDA 483 Observations
This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...
Quality & Compliance
FDA Form 483: Common Pitfalls You Can Avoid
This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...
Meet the Expert: Valerie Huh
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...
Who’s Watching? Why You Should Care About Global Promotional Material Review
Recently, there have been two notable cases regarding pharmaceutical advertising code violations based on LinkedIn content. It was announced that Danish drugmaker Novo Nordisk has been suspended by...
EMA’s Regulatory Science Strategy to 2025 is on Track
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
How to Maximize the Value of Cell and Gene Therapy Products: 5 Tips for Success
This article has been updated since its original publication date. Product development is an extremely time consuming and challenging process for any pharmaceutical, biotechnology, or medical device,...