Latest Developments and Insights

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…

One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the FDA released the Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, which supported a phase appropriate approach…

05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do their first in human clinical trials in Australia? Are there any real advantages or are people just looking for an…