With much of the world focused on the response to COVID-19, many biopharmaceuticals are looking at new ways that they ...

Are your aging Quality Management Systems (QMS) and the problems that come with them keeping you up at night?  Upgrading your ...

Many pharmaceutical products, including vaccines, can require special cold chain handling during manufacturing and distribution. In particular, biologics such as ...

Laboratory Information Management System (LIMS) implementations can be challenging due to the cost, commitment of resources, and other competing priorities ...

Over the past few weeks inequities and health disparities in quality of care have been highlighted with reports showing how ...

Clarkston recently partnered with a biopharmaceutical company on their FDA inspection readiness for business systems project. This company develops, manufactures, ...

After two years of stalled progress on approving legislation for FDA reform of Over the Counter (OTC) Monograph Drug Review, ...

Optimizing HCP engagement through digital marketing will give companies a noticeable leg up, especially now. Life sciences companies that become ...

You are in the middle of an FDA inspection and a significant issue just surfaced.  How you handle the situation ...

In September of this year, the FDA plans to release guidance on the transition from the traditional concepts of Computer ...

Changes are all around the medical device industry, especially with the upcoming European medical device regulations deadlines quickly approaching. Revenue ...

In this case study, we describe our partnership with a biopharmaceutical client to help them tackle their global Quality Management ...