Blog Post Consulting Services Quality + Compliance Global Governance and Support for Serialization “We’ll cross that bridge when we get there.” This is the typical approach most of us take on post-production matters ...
Blog Post Consulting Services Contract Manufacturing Trading Partner Integration for Serialization As if serialization efforts aren’t complicated enough working within our own manufacturing organizations, syncing our efforts with our trading partners ...
Blog Post Consulting Services Quality + Compliance Validation for Serialization – The Longest Pole in the Tent As organizations plan their serialization initiative, I often find that the effort required to validate the complete solution is underestimated. ...
Article Biotech Contract Manufacturing FDA’s Final Rule on Combination Products Combination drugs continue to grow in popularity as novel alternatives and advances in biotechnology, pharmaceuticals and medical devices. The market ...
Article Consumer Products Contract Manufacturing Philly Life Sciences Executive Exchange Recap Our Philly Executive Exchange community recently came together for a great discussion on 2013 life sciences trends. We were joined ...
Blog Post Consulting Services Quality + Compliance Removing the Mystery for Serialization Stakeholders In my last blog, Piloting Serialization for the Real World, I highlighted that many organizations implementing serialization are very focused ...
Article Biotech Consulting Services Europe’s Drug Pricing Approach Creates Challenges Austere times in Europe continue to challenge local governments to reduce healthcare spend. Leveraging Europe’s reference pricing policies, Eurozone countries ...
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), ...
