AI in GxP: Recurring Compliance Gaps
Artificial intelligence (AI) is increasingly embedded in compliance areas like medical information, pharmacovigilance, clinical operations, manufacturing, quality systems, and other regulated processes.

Full-Service CRO
Customer perception and satisfaction play a pivotal role in shaping the success and reputation of pharma companies. Given the significance of these factors, it's understandable that many pharma...

Full-Service CRO
Leadership at drug and devices companies are continually overwhelmed with the constant balance of driving daily work, managing resources, and addressing unplanned emergencies. This balance is then...

Digital Transformation
Across biotech startups and global pharmaceutical companies alike, Veeva Vault continues to expand market share. With 1,300+ customers, Veeva Systems is one of the largest providers of cloud...

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...

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...

Full-Service CRO
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...

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...

Full-Service CRO
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...

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...

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
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...

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...

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...

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...

What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...