Organizations that implement Quality by Design (QbD) fundamentals are well-positioned to avoid disruptions in product supply rather than those who ...

In this case study, learn how Clarkston Consulting supported quality management for a CRO to achieve cost savings while maintaining ...

In this Lean Laboratory assessment case study, Clarkston Consulting recently partnered with a national contract laboratory to enhance their lab ...

On September 8, 2025, the U.S. Food and Drug Administration (FDA) posted the final version of E6(R3) Good Clinical Practice (GCP) on its website and ...

Clarkston Consulting recently partnered with a CDMO on a LabVantage LIMS implementation dashboard assessment. Read a synopsis of the project ...

In January 2025, the FDA banned synthetic food dye Red No. 3 under the Delaney Clause due to concerns over health risks. The food and ...

Today, life sciences firms are facing increased regulatory complexity, huge volumes of data, and increased pressure to bring safe therapies ...

Selecting an Electronic Quality Management System (eQMS) is one of the most important technology decisions a life sciences organization can ...

Steve Jobs said in 2003 in reference to his business model, “Great things in business are never done by one ...

As digital transformation continues to reshape laboratory operations, Electronic Lab Notebooks (ELNs) have become a critical role in laboratory informatics. ...

Below, our Veeva experts provide their perspective on insights from the 2025 Veeva MedTech Postmarket Quality Benchmark Report.  The medtech ...

Clarkston Consulting partnered with a biotechnology company to develop a comprehensive GMP data integrity training program. Read a synopsis of the ...