Over the past several years, there has been a rapidly growing interest in applying Artificial Intelligence (AI) to nearly all sectors of the life sciences industry, especially in global medical writing. With its use in drug discovery1, clinical trial design2, and...

The US Food and Drug Administration’s (FDA) Knowledge-aided Assessment and Structured Application (KASA) review method is endeavoring to expand into drug substances. This is intended to support and address quality system related challenges that are related to New Drug...

Pharmacovigilance auditing is a critical function, as drug safety is a primary concern for pharmaceutical companies throughout the drug development lifecycle and beyond. Yet, the evaluation of drug safety is complicated due to safety monitoring requirements which...

In the dynamic and highly regulated pharmaceutical industry, time is often as critical as the quality of the submissions to health authorities. A leading US-based pharmaceutical company recently encountered a substantial challenge: submitting a Supplemental New Drug...

The FDA released a draft guidance in September 2023 regarding Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. They're accepting public feedback on this guidance until December...

Change management in the pharmaceutical industry is Part 2 in our conversation on computer system validation (CSV). As discussed in Part 1, the increase in the use of automated manufacturing and quality systems is forcing an increased exposure on computer systems...

Clinical data science is growing exponentially, as the Bureau of Labor Statistics confirms that the need for data scientists is rising faster than other areas with a 35 percent project growth rate through 2032. And, as the pharmaceutical industry has seen in the last...