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 with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and combination products are turning to external consultants with specialized expertise and a deep understanding of ever-changing quality regulations. This approach allows these companies to supplement their internal teams cost-effectively. Read more »

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 actionable improvement recommendations and incorporates validated best practices to ensure robust solutions. I found this analysis extremely insightful and wanted to share it with you: Read more »

Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan

Insights From Combination Products Summit

The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because different countries have their own definitions and requirements for these products. This lack of uniformity complicates the application process, adding layers of complexity and burdening manufacturers. Read more »