Blog Post Supply Chain Consumer Products Review of Executive Order 14017: The 100-Day Assessment on Critical Supply Chains Over the last year and a half, shortages in medicine, PPE, and household products strained global supply chains. In response ...
Case Study Retail Consumer Products CCPA Compliance: Data Protection and Privacy Clarkston Consulting recently partnered with a global retailer to achieve CCPA compliance. The client owns and operates a chain of ...
Blog Post Consumer Healthcare Consumer Products OTC to DTC: Regulatory Considerations for Moving to Direct-to-Consumer Healthcare In today’s new age of the consumer, industries that may not have considered a direct-to-consumer (DTC) play before are now ...
Case Study Quality + Compliance Pharma LIMS “Go Paperless” Project: Digital Transformation The client develops and manufactures pharmaceutical products for a wide range of medical disciplines. Specifically, the Vaccine Research and Development ...
Blog Post Quality + Compliance Life Sciences Moving From a LIMS Assessment to a LIMS Deployment Laboratory Information Management System (LIMS) implementations can be challenging due to the cost, commitment of resources, and other competing priorities ...
Blog Post Consumer Healthcare Life Sciences OTC Monograph Process FDA Reform After two years of stalled progress on approving legislation for FDA reform of Over the Counter (OTC) Monograph Drug Review, ...
Multimedia Quality + Compliance Consumer Products Addressing an FDA Form 483 You are in the middle of an FDA inspection and a significant issue just surfaced. How you handle the situation ...
Blog Post Medical Device Life Sciences How the Upcoming European Medical Device Regulations Deadlines Impact You Changes are all around the medical device industry, especially with the upcoming European medical device regulations deadlines quickly approaching. Revenue ...
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 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 ...
