Clarkston’s team of life sciences consultants have highlighted the top quality and compliance trends that businesses should consider. See an ...

For late-stage biotech and biopharma organizations, ensuring GxP commercial launch readiness is critical to achieving success, and there are key ...

Read our updated trends report here: 2025 Quality and Compliance Trends Clarkston’s team of life sciences consultants have highlighted the ...

It’s critical for pharmaceutical, medical device, and biotech companies to always be ready for an announced or unannounced inspection by ...

The Remote Regulatory Assessment (RRA) was originally introduced in an April 2021 Guidance for Industry as a Remote Interactive Evaluation ...

It’s critical to have a good understanding of the processes used within your company, but how do we best document ...

As companies are trying to remain leaner, what are some steps they can take now to ensure they’re getting the ...

The use of password managers to create, store, and reuse passwords across different systems and applications has gained popularity in ...

Quality management has come a long way since the days of simply inspecting finished products for defects. With the advent ...

The FDA has recently updated two compliance program guides addressing PAI inspections (7346.832) and routine GMP surveillance inspections (7356.002). This ...

The benefits to having a Quality Management System (QMS) are generally well known and understood. Having a quality framework throughout ...

When organizations implement metrics, there is often the urge to track and trend any and every data point. The presence ...