March 3, 2025
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, […]
February 12, 2025
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 […]
February 11, 2025
Learn how to prepare for FDA inspections, engage with inspectors, and respond to findings with expert support from DS InPharmatics.
January 20, 2025
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 […]
January 6, 2025
In the pharmaceutical industry, the successful transition of a drug substance from the controlled environment of the laboratory to large-scale production at a manufacturing plant is critical. This process, known as technology transfer, ensures that the product maintains its quality, integrity, and compliance with regulatory standards at every scale. At […]
December 10, 2024
ProductLife Group (PLG), a trusted global leader in regulatory, scientific, compliance, and digital transformation consulting services for the life sciences, today announced the acquisition of Halloran Consulting Group, a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support in the pharmaceutical, biotechnology, and medical device sectors in the United States, further positioning PLG as a leading global provider of comprehensive healthcare services.
