Article Medical Device Consulting Services Medical Device Vulnerability The Department of Homeland Security is currently investigating dozens of cybersecurity cases related to medical devices and their potential for ...
Blog Post Consulting Services Information Technology Analytics in Life Sciences: Manufacturing and Quality The first post in the Analytics in Life Sciences blog series covered New Product Development. Today, we will look at ...
Article Biotech Generics 2015 GPhA Annual Meeting Brings Together Generics Industry Leaders Clarkston Consulting attended the Generic Pharmaceutical Association (GPhA) Annual Meeting earlier this month in Miami, Florida. This annual meeting is the ...
Multimedia Consulting Services Quality + Compliance United States Drug Supply Chain Security Act (DSCSA) Requirements and Implications for the Pharmaceutical Industry Download PDF
Blog Post Quality + Compliance Consumer Products Consumer Products Quality Systems Validation: You’re Not Alone Throughout this blog series, I have asked a number of Clarkston experts to discuss several different topics with respect to ...
Multimedia Consulting Services Pharma Quality in Generic Pharmaceuticals: Part 3 Over the last two years, Clarkston Consulting has released its study on Quality in Generic Pharmaceuticals. As in the past, ... Download PDF
Blog Post Consulting Services Biotech The Growth of Regenerative Medicine An article published this month in New York Magazine highlights the recent advancements to the regenerative medicine and medical device ...
Article Consulting Services Quality + Compliance Serialization & Manufacturing Expansion When a company’s ability to compete depends on the speed at which products can be supplied to the market, opening ...
Blog Post Consumer Products Quality + Compliance QSV: How to Keep Your Supply Chain Compliant I’ve asked Melanie Drayton to share some ways that Consumer Products companies can meet supply chain compliance sanctions. Leveraging her experience ...
Article Consulting Services Medical Device MMA Roadshow: Managing mHealth App Development One of our experts was recently a panelist at the MMA Roadshow workshop on “Managing App Development under FDA Regulation,” ...
Multimedia Consulting Services Medical Device Life Sciences Supply Chain Security: SNI and UDI In 2013, US Customs & Border Protection seized more than 2,350 parcels containing counterfeit medical devices and pharmaceutical products valued ... Download PDF
Blog Post Quality + Compliance Consumer Products How to Make Quality Systems Validation Less Daunting As we have talked about through this series, by definition, Quality Systems Validation is the action of proving, in accordance with applicable ...
