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 […]
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 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 […]
