Pharma's growing interest in probiotics - a challenge or an opportunity?

According to the US FDA definition, probiotics are classified as Live Biotherapeutic Products (LBP) i.e. products that contain live organisms such as bacteria or yeast, found naturally in humans. The most common bacteria belong to the groups Lactobacillus and Bifidobacterium. Probiotics have a long global history of traditional use. Normally consumed through fermented foods and sold mostly as ingredients in foods or nutritional supplements. There is a thin line between nutritional supplements and drugs.

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Non-clinical safety evaluation of vaccine: strategic considerations to accelerate clinical development

Download our recent whitepaper on Non-clinical safety evaluation of vaccine and gain valuable insights about the step-wise process comprising preclinical proof of concept, non-clinical development (efficacy, quality, and safety), and clinical development of a vaccine.

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Together Beyond COVID-19: Key trends that have been accelerated by the pandemic

Coronavirus has shattered our world and changed nearly all aspects of our lives. It has also changed our relationship with healthcare. It is slowly becoming a cliché to say that COVID-19 has catalyzed life sciences and healthcare trends – but nevertheless, it’s true. Industry leaders and PharmaLex experts recently discussed the key trends being accelerated since the start of the COVID-19 pandemic. This paper summarizes the main points of their discussions as well as the possible implications of these trends.

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Together Beyond COVID-19 - A Look at the Future

In cooperation with EY, open-ended interviews were conducted with top pharmaceutical companies around Europe to understand the challenges that the pharmaceutical industry faces during COVID-19. This paper summarizes the main highlights, together with the future vision.

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The Medical Device Regulation – Readiness for May 2021

This paper highlights what medical device manufacturers and other Economic Operators must be aware of ahead of the revised May 2021 deadline.

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Software, AI and Medical Devices - What's Up?

This paper highlights just a few key points that need consideration ahead of the new Medical Device Regulation 2017/745 (MDR) being implemented in 26th May 2020.

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