by Prakash Achaary | Feb 7, 2024 | Blog
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...
by Prakash Achaary | Jan 29, 2024 | Blog
The FDA released a draft guidance in September 2023 regarding Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory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...
by Prakash Achaary | Jan 10, 2024 | Blog
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...
by Prakash Achaary | Jan 4, 2024 | Blog
Computer system validation (CSV) is a core item that regularly comes up during regulatory inspections. And, the US Food & Drug Administration (FDA) conducted 2,442 inspections in 2022, according to a recent report. To ensure inspection readiness, a two-part series...
by Prakash Achaary | Dec 27, 2023 | Blog
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...