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Understanding the Nuances of a Clinical Study Protocol

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…

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Why Regulatory Affairs is Important in Drug Approval

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.…

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What is a Regulatory Affairs Project Manager?

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…

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Navigating Regulatory Affairs for Clinical Trials

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…

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Exploring Risk-Based Approaches to Raw Material Testing in Pharmaceutical Manufacturing

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…

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Potency Assurance for Cellular and Gene Therapy Products

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…

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