November 27, 2024
Learn the critical factors to consider before partnering with a CDMO, ensuring your drug development project aligns with the right expertise and capabilities.
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.
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 […]
January 11, 2025
Regulatory compliance defines success in biopharmaceuticals and medical devices. A missed step can lead to recalls, financial losses, or patient harm. Quality assurance (QA) consultants, like DSI, help companies tackle these risks. Our expertise strengthens compliance strategies, mitigates issues, and boosts operational efficiency. Learn how quality and compliance consulting secures […]
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 […]
February 11, 2025
Learn how to prepare for FDA inspections, engage with inspectors, and respond to findings with expert support from DS InPharmatics.