Blog Post Biotech Consulting Services Paving the Way for Personalized Medicine Yesterday, an FDA panel started writing the first chapter in the new novel of modern medicine. With a unanimous recommendation ...
Blog Post Consulting Services Pharma Embrace the Industrial Internet of Things to Improve Quality Compliance For any industry, the ability to connect data points, maximize equipment efficiency, and extract performance insights are well-documented advantages of ...
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 Medical Device Information Technology Tactics for Improving Medical Device Cybersecurity 1,266,000. That’s how many web attacks were blocked, not counting successful attacks, per day in May 2017, according to Symantec’s Internet Security Threat Report …and that doesn’t include spam, ...
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 Quality + Compliance Data Integrity Problems Break Trust, Part 3 In part one of this series, I talked about data integrity at its most basic level – including what it ...
Blog Post Consumer Products Consumer Healthcare Cosmetics Companies Facing New Regulatory Oversight The United States Senate and House of Representatives are both working on new regulations that would significantly impact the cosmetics ...
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 Quality + Compliance Data Integrity Problems Break Trust, Part 2 Since my first post in this series, the FDA has issued two more warning letters regarding data integrity to drug ...
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 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 ...