Blog Post Quality + Compliance Life Sciences Moving from Validation to Computer System Assurance In September of this year, the FDA plans to release guidance on the transition from the traditional concepts of Computer ...
Case Study Quality + Compliance Life Sciences Global QMS Process Redesign In this case study, we describe our partnership with a biopharmaceutical client to help them tackle their global Quality Management ...
Blog Post Quality + Compliance Life Sciences Why Invest in a Quality Management System (QMS)? Why Invest in a Quality Management System? It’s not uncommon for a small- to mid-sized companies to use a paper-based ...
Article Pharma Quality + Compliance Drug Supply Chain Impact Due to COVID-19 The global outbreak of the Coronavirus Disease (COVID-19) and its impact both socially and economically across the world’s continents has ...
Multimedia Consumer Products Quality + Compliance Risk Management: Taking Stock with David Patterson Welcome to Taking Stock, a podcast designed to discuss some of the most pressing issues facing corporate executives. This podcast series is ...
Blog Post Biotech Pharma FDA Gene Therapy Guidances: The Latest Updates Explained On January 28, 2020, the highly anticipated final FDA gene therapy guidances were released. In total, 7 guidance documents were ...
Blog Post Sales + Marketing Consumer Products 1 Month Until CCPA Goes Into Effect, Is Your Business Prepared? California’s Consumer Privacy Act (CCPA) will go into effect in 1 month. Why is it important and why should direct-to-consumer, ...
Blog Post Consumer Products Grocery CBD in Retail: What Do Retailers Need to Know? [Update] Since the original publication of this piece, the FDA has issued more information on its position relative to CBD. The ...
Blog Post Quality + Compliance Consulting Services How Does the FDA Regulate Mental Health Apps? The rise of mental health apps promises an accessible option for diagnosis and treatment as more individuals want to be ...
Blog Post Consumer Products Food and Beverage Food Safety and Recalls: Emerging Regulations Governing US Based Food Companies The FDA’s 2011 Food Safety Modernization Act (FSMA) has been transforming the U.S. food safety system, with ongoing implementation creating ...
Blog Post Biotech Quality + Compliance What is the Future of Liquid Biopsy Diagnosis? The promising outlook for liquid biopsy diagnosis has sparked the interest of many in the biotech industry. The speed, ease, ...
Blog Post Research + Development Consulting Services Stepping Away from Convention in Clinical Trial Design Clinical trial design, like much of the industry, is experiencing a wave of innovation and disruption. Classical randomized control trials ...
