Article Biotech Consumer Products Global Quality Leaders Convene for GMP, GCP & Quality Control Summit The 2nd International Summit on GMP, GCP & Quality Control took place recently at the DoubleTree by Hilton Hotel Chicago ...
Article Biotech Consumer Products Annual BSMA Meeting Brings Together Supply Chain Leaders The annual meeting of the Bio Supply Management Alliance was held on October 8th, 2013, and was well-attended by key ...
Article Consulting Services Generics Proposed Labeling Rule Has Serious Implications for Generics Industry The FDA has recently proposed new labeling requirements for generic pharmaceutical companies. Current regulations do not allow generics companies to ...
Multimedia Consulting Services Quality + Compliance One More Look at Quality Systems Maturity A key activity in optimizing product quality is critically assessing your quality systems against proven quality maturity models – such ... Download PDF
Multimedia Consulting Services Quality + Compliance At the Serialization Crossroads: Deciding Which Path to Take Pharmaceutical manufacturers are confronted with a major decision regarding compliance with current and impending serialization requirements for products they sell ... Download PDF
Article Biotech Consumer Products Pennsylvania Bio Leadership Panel Program: Fall CEO Roundtable On September 18th, 2013, Clarkston co-sponsored and attended Pennsylvania Bio’s Leadership Panel Program’s Fall CEO Roundtable, which brought together executives, ...
Article Biotech Consulting Services Crowdfunding: Breathing New Life into Biotech? The road to market for a novel biotech therapy is among the most expensive, demanding courses for entrepreneurs to undertake, ...
Blog Post Consulting Services Quality + Compliance Regulations, Red Tape, or Something Worse? Last week, a major pharmaceutical company, Eisai Inc., sued the Drug Enforcement Administration (DEA), the very agency that stands between ...
Article Generics Consulting Services Generics Manufacturers Not Liable for the Design of Drugs In the case of Mutual Pharmaceutical Co. Inc. v. Bartlett, the Supreme Court overturned a lower court ruling that awarded ...
Article Biotech Consumer Healthcare Sustainable Capitalism at the ICGN Annual Conference Fortune 500 CEO Indra Nooyi recently provided her perspectives on sustainable capitalism at the ICGN Annual Conference in New York ...
Article Generics Consulting Services Pay-for-Delay and the Rule of Reason The economics of pay-for-delay agreements are clear – branded drug makers benefit from an extended amount of time on the ...
Blog Post Consulting Services Quality + Compliance Managing a Mixed Warehouse In one of my earlier blogs, Removing the Mystery for Serialization Stakeholders, I talked about the need to identify internal ...
