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The Role of the LPPV in Switzerland and Liechtenstein: Navigating Local PV Responsibilities in DACHL (Part 2)

As we continue exploring pharmacovigilance (PV) requirements in the DACHL region, this second part of the blog series covers the local roles and obligations in Switzerland and Liechtenstein. While part 1 focused on Germany and Austria, this post highlights the unique regulatory landscapes of these...

Man looking at two arrows pointing in opposite direction

Clinical Research Solutions

To Requalify or to Continuously Monitor, That is the Question

Your manufacturing equipment and processes have been established, qualified and validated; all you have to do now is rake in the profits right? Think again, the process of maintaining the validated...

Example of an submission process workflow.

Clinical Research Solutions

Words, Words, Words: The Importance of Diction in Regulatory Submissions

In continuation of its series of guidances on electronic submissions, FDA recently released a guidance for receipt dates of electronic submissions which emphasizes one important fact: word choice...

Clinical Research Solutions

Computer System Validation: Resolutions for the New Year

How are you doing with those New Years’ resolutions? Whether or not you’re a resolution maker (or breaker), you can use this time of year to take stock of where things stand, including your validated...

Clinical Research Solutions

Impact of Wavelength Accuracy and Precision on Spectrophotometric Measurements

Impact of Wavelength Accuracy and Precision on Spectrophotometric Measurements: A while back I was involved in a Quality Assurance project reviewing calibration specifications for analytical...

Quality & Compliance

Formulation and Process Development: Gate 6 of the Nine Gate Transfer Process for Moving Production

Today, we are continuing our blog series on the Nine Gate Transfer Process for Moving Production from Site to Site, with Gate 6: Formulation and Process Development. If you have missed any previous...

Clinical Research Solutions

FDA Revisits the Topic of INDs for Dietary Supplements

One of the fundamental disconnects in the dietary supplement world is that despite the fact that manufacturers of dietary supplements are not allowed to make claims regarding effects on diseases,...

Clinical Research Solutions

U.S. Attorneys Send Strong Message that a Company’s Response to a Compliance Issue is Key Element of an Effective Compliance Program

A common theme among the government enforcers speaking at last week’s Pharmaceutical Compliance Congress (PCC) was the importance of putting in place an effective corporate compliance program to...

Clinical Research Solutions

What’s the Skinny on Dietary Supplements?

One doesn’t have to spend much time in a pharmacy, grocery store or even a typical American house to see that dietary supplements have found a place in people’s lives. In fact, roughly 54% of U.S....

Clinical Research Solutions

GMP Documentation: Gate Five of the Nine Gate Transfer Process for Moving Production

Today we’re back with the next step in the Nine Gate Transfer Process for Moving Production from site to site. So far we’ve covered the first four gates, which you can review in our last blog post....

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