Blog Post Consulting Services Biotech DSCSA Enforcement Delay – What It Means for You On June 30, 2017, the FDA published a draft guidance announcing an enforcement delay for the pharmaceutical manufacturer’s requirement under ...
Blog Post Consulting Services Generics GDUFA II Fees – What You Need to Know The Generic Drug User Fee Amendment (GDUFA II) will go into effect on October 1, 2017. It will create a ...
Blog Post Supply Chain Contract Manufacturing Serialization Challenges and Solutions: Integrating CMOs Co-author and contributions by Megan Weldon Over the next few years, global and multinational pharmaceutical companies will need to achieve ...
Blog Post Consulting Services Consumer Products The Repatriation of Outsourced Services To answer questions about the impact of new US tax legislation, repatriation of outsourced services, and tax-efficient supply chains, I ...
Blog Post Consulting Services Generics So, You’re in Danger of Missing the DSCSA Serialization Deadline… With a major regulatory deadline approaching this year, pharmaceutical manufacturers across the globe are in varying stages of compliance with ...
Blog Post Consulting Services Biotech 2017 Life Sciences Trends Report Over the past decade or more, phrases like “value-based care” and “patient centricity” have evolved to a position of greater ... Download PDF
Blog Post Quality + Compliance Biotech Data Integrity Problems Break Trust, Part 1 Embedded in nearly every quality or regulatory project for Clarkston is a focus on foundational data integrity principles to not ...
Blog Post Consulting Services Generics The Government Can’t Have It Both Ways When It Comes to Generic Drugs On February 28th in his address to Congress, President Trump urged legislators to bring down drug prices ‘immediately.’ And, the ...
Blog Post Consulting Services Biotech Is Your LIMS Master Data Green? [Reduce] In addition to working with some of the most innovative companies in the life sciences industry, one of the greatest ...
Blog Post Generics Consulting Services 3 Operations Themes from the 2017 GPhA Annual Meeting Last week, we were fortunate to attend this year’s GPhA Annual Meeting in Orlando, FL. As always, the event offered ...
Blog Post Generics Consulting Services 3 Technology Themes from the 2017 GPhA Annual Meeting Last week, we were fortunate to attend this year’s GPhA Annual Meeting in Orlando, FL. As always, the event offered ...
Blog Post Consulting Services Generics 3 Strategic Themes from the 2017 GPhA Annual Meeting Last week, we were fortunate to attend this year’s GPhA Annual Meeting in Orlando. As always, the event offered opportunities ...
