Navigating FDA Changes: What Life Sciences Professionals Need to Know The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political [...]

Navigating Regulatory and Patent Challenges in the Combination Products Space The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a [...]

Prepare Your Quality Management System for QMSR Compliance by February 2026 With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for [...]

Outsourcing with Confidence: A Guide to Successfully Hiring Specialty Expertise Consultants in Healthcare Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced [...]

Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, [...]

Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers [...]