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.
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 […]
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, […]
March 14, 2025
Bringing a new drug to market requires more than just scientific innovation. It demands rigorous quality control, reliable manufacturing, and strict adherence to global regulatory standards. Agencies such as the FDA, EMA, MHRA, and PMDA impose Chemistry, Manufacturing, and Controls (CMC) requirements to ensure pharmaceutical products remain safe, effective, and […]
March 28, 2025
Navigating the complexities of regulations in pharmaceuticals, biotechnology, or medical devices demands precision and expertise. Current Good Manufacturing Practices (cGMP) compliance isn’t optional—it drives business success and safeguards public trust. cGMP quality compliance consulting transforms these challenges into opportunities by crafting targeted strategies and delivering actionable guidance to ensure your […]
April 4, 2025
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 […]
April 4, 2025
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 […]