Blog Post Consulting Services Quality + Compliance Serialization Pilot for the Real World With 2015 looming, many pharmaceutical companies are well down the path of serialization. Most of these companies are designing and ...
Article Biotech Generics Insights from the 2013 GPhA Conference Clarkston Consulting recently participated in the GPhA Annual Meeting in Orlando, FL. This signature event creates a forum for generic ...
Article Biotech Consumer Healthcare Integrated Reporting: The Next Generation of Transparency Recent hype about John Mackey’s “Conscious Capitalism” has drawn attention to the business shift from shareholder to stakeholder value. Increasingly, ...
Blog Post Quality + Compliance Contract Manufacturing To Serialize or Not to Serialize – That’s no longer the question Most Pharma companies have been taking a “wait and see” approach to starting a Serialization and Traceability initiative, hoping that ...
Article Biotech Generics FDA Reform Bill Heading Towards Obama The 2012 FDA reform bill, which includes a fifth, five-year reauthorization of the Prescription Drug User Fee Act (PDUFA V), ...
Article Biotech Consumer Products Serialization at SAPPHIRE Clarkston Consulting is participating – and presenting – this week at the 2012 SAPPHIRE NOW + ASUG Annual Conference in ...
Multimedia Consulting Services Quality + Compliance Solution Overview: Serialization & Traceability With regulatory requirements looming and a growing desire to prevent counterfeiting, tampering, theft, and diversion, companies must begin to look ... Download PDF
Article Biotech Contract Manufacturing Working with the FDA to Get Your Drug to Market This week, Joe D’Ambrosio from Clarkston Consulting moderated a panel of industry experts at the most recent CED Biotech Forum.
Article Contract Manufacturing Generics 2012 Life Sciences Industry Outlook The Life Sciences industry faces a multitude of challenges and threats moving into 2012, but within each challenge lies great ...
Multimedia Consulting Services Quality + Compliance Looking Ahead with Quality Systems In April 2011, the Food and Drug Administration (FDA) released an update of its strategic priorities, outlining the goals and ... Download PDF
Multimedia Consulting Services Quality + Compliance Reaching the LIMS Promise Over the past decade, in our experience working with Life Sciences companies, we have seen many companies fail to achieve ... Download PDF