by Dr. Yashashwini Reddy | Apr 10, 2025
The need for regulatory affairs (RA) professionals is prominently recognized within the pharmaceutical sector, consulting firms, clinical research organizations, and regulatory bodies. As I contemplated my career shift from laboratory science to regulatory affairs, I...
by Dr. Yashashwini Reddy | Apr 8, 2025
Feature Regulatory Affairs Quality Assurance Focus Legal compliance and market access Product quality and consistency Scope Entire product lifecycle, with an emphasis on regulatory requirements Entire product lifecycle, with an emphasis on quality standards Primary...
by Dr. Yashashwini Reddy | Apr 8, 2025
Various types of regulatory submissions are essential in the pharmaceutical and medical device industries. These include Investigational New Drug (IND) applications for clinical trials, New Drug Applications (NDAs) for new pharmaceuticals, Biologics License...
by Dr. Yashashwini Reddy | Nov 21, 2024
What is Analytical Validation? Why Is It Done? Analytical validation is a vital process in the pharmaceutical industry, ensuring the methods used for drug analysis are accurate, reliable, and consistent. By validating analytical methods, pharmaceutical companies...
by Dr. Yashashwini Reddy | Oct 9, 2024
Selecting Die Size for Blend Uniformity Sampling in the Pharmaceutical Industry In pharmaceutical manufacturing, ensuring blend uniformity is critical for the quality and consistency of drug products. One key factor in achieving this is selecting the right die size...
