IMPACT ON COMBINATION PRODUCTS AND COMPANION DIAGNOSTICS

July 19, 2019

With the end of the Medical Device Regulation’s (MDR) transition period looming (May 26th, 2020), manufacturers of drug device combination products or companion diagnostics are under heightened time pressure to comply with the new Regulation. Any company manufacturing or distributing these products risks losing European market access unless their products meet the latest regulatory requirements.

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Tepnel Pharma Services

Tepnel Pharma Services is an independent Contract Research Organisation which supports the drug development pipeline at the Rx/Dx interface.

OTHER WHITEPAPERS
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Research and Development in the Pharmaceutical Industry

whitePaper | April 1, 2021

Every year, the U.S. pharmaceutical industry develops a variety of new drugs that provide valuable medical benefits. Many of those drugs are expensive and contribute to rising health care costs for the private sector and the federal government. Policymakers have considered policies that would lower drug prices and reduce federal drug expenditures. Such policies would probably reduce the industry’s incentive to develop new drugs.

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Utilizing Multi-parameter Epitope Binning to Understand aTherapeutic Antibody’s Mechanism of Action

whitePaper | January 20, 2023

Understanding an antibody’s mechanism of action (MOA) is critical to its clinical success. Not only does MOA have a large impact on safety and efficacy.

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The Annual Clinical Trials Round-up 2021

whitePaper | October 13, 2022

In our previous edition of the Clinical Trials Roundup1, we explored the acute disruptions that the COVID-19 pandemic brought to the clinical trials landscape in 2020.

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Overcoming technical challenges in cell-based high throughput screens

whitePaper | November 11, 2022

Tremendous technological advancements in automated biotechnology and combinatorial chemistry have led to the widespread implementation of high throughput screening (HTS) for drug discovery since the early 1990s.

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The SwedishDrug Discovery and DevelopmentPipeline 2023

whitePaper | March 23, 2023

Sweden is and should remain a leading life sciences nation. The life sciences industry is one of Sweden’s economic base industries with a signifi cant share of our exports.

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Pharma R&D Annual Review 2023

whitePaper | April 20, 2023

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

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Spotlight

Tepnel Pharma Services

Tepnel Pharma Services is an independent Contract Research Organisation which supports the drug development pipeline at the Rx/Dx interface.

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