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In 2023, a small pharmaceutical company faced a critical Refusal-to-File (RTF) decision from the FDA for their New Drug Application (NDA). The letter outlined numerous deficiencies, including incomplete stability data, poorly organized information, and inconsistencies in the Chemistry, Manufacturing, and Controls (CMC) section. With deadlines looming and expertise limited, the […]

Cost estimation in drug product manufacturing is far from straightforward. Raw materials, labor, equipment, and quality and regulatory compliance all contribute to a complex web of expenses. Striking the right balance between operational efficiency and budget constraints poses a significant challenge for pharmaceutical companies. This balancing act becomes even more […]

Qualified person (QP) certification and declaration are distinct in their objectives within pharmaceutical and biotech industries. However, their similar names and overlapping functions can lead to confusion – particularly for those outside the EU/UK regulatory framework. Here’s a quick overview: Together, these processes are essential for maintaining EU regulatory compliance, […]

For early-stage drug developers, engaging with the FDA at the right time can be critical to success. One such opportunity is the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting. This meeting provides early-stage guidance from the FDA’s Center for Biologics Evaluation and Research (CBER) and Center […]

The path to FDA drug approval involves several critical milestones, one of the most important being the Pre-New Drug Application (Pre-NDA) meeting. This crucial step provides pharmaceutical companies with an opportunity to engage with the FDA before submitting a New Drug Application (NDA). Understanding the significance of a Pre-NDA meeting […]