Latest Developments and Insights

The eCTD (electronic Common Technical Document) is the standard format the pharmaceutical industry uses to submit regulatory information to agencies worldwide. For the last 20 years, the eCTD has provided the structure to facilitate the review of pharmaceutical products through…

One of the first recommendations that I received as an entry-level medical writer when I started writing clinical study protocols (or simply called protocols) was “not all protocols are created equally”. This may seem obvious, but as I gained more…

Regulatory affairs is critical for the successful approval of new drugs. Regulatory affairs consultants and professionals guide the complex journey from pre-clinical to market, managing rigorous testing, compliance with global standards, and ensuring drugs are safe and effective for consumers.…

A regulatory affairs project manager (RAPM) is a pivotal figure in the compliance and regulatory integrity of products or drug development within the biopharma industry. This role demands a comprehensive understanding of biopharma-specific regulations, meticulous project management skills, and effective coordination with…

Understanding the intricacies of navigating regulatory affairs for clinical trials is pivotal in shaping the path to successful medical research and innovation. These regulations form the backbone of ensuring that your trials are not only compliant but also set up…

In the rapidly evolving pharmaceutical industry, the quality and safety of drug substances and products hinge significantly on the integrity of raw materials used in their manufacture. A risk-based approach to raw material testing and specification setting has emerged as…