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Understanding Compliance: Moving from Cost to Value

Throughout the life sciences sector, the key trends of globalisation and digitalisation are providing new opportunities for growth and innovation. However, within development facilities, quality …

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EU CTR: Final Countdown, What You Need to Know

The end of the transition period is imminent. How can clinical trial sponsors and CROs ease the transition to CTIS? Soon, the one-year transition period …

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Brexit – Impact, Challenges, and Solutions for The Pharmaceutical Industry

Brexit has provided several challenges to the pharmaceutical industry that required robust actions and swift resolution in order to remain in compliance following the end …

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Bad Medicine: Lessons from an Enduring Alliance between Big Pharma and Global Policing

The challenges of tackling international crime with national law enforcement are legion. John Binns, a partner in the Financial Crime team at BCL Solicitors considers …

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Current Features

Driving a Vision for a Data-driven Regulatory Ecosystem

A data-driven Regulatory ecosystem has huge potential, beyond the opportunity for operational improvement. However, Regulatory and product teams will need updated data skills to deliver …

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Regulatory and Developmental Complexities Around Demonstrating Bioequivalence for a Topical Generic Product

Increasing Patient Access to HighQuality Topical Products The topical dermatology market, although niche, was estimated to be valued at approximately $20.4 billion in 2020.1 In …

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Opportunities for the IPO of Psychedelics Companies (or, How to Change Investors’ Minds)

If anyone had suggested only a few years ago that it is a realistic proposition to float a psychedelics company on any of the London …

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Technical Advancements in Proteomics Streamline High-throughput Workflows

Over the last two decades, significant advances in technology and new methodologies have made proteomics an extremely powerful tool for protein scientists, biologists and clinical …

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Pre-existing Immunogenicity: How Will Cell and Gene Therapies Change Our Testing Approach?

When bringing a therapeutic to market, determining its potential to elicit an immune response and understanding the molecular and cellular interactions involved is essential. In …

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Strategies to Reduce Cold Chain Burden in Biopharmaceuticals

The availability of a wide range of therapeutic biologics has revolutionised modern medicine. Whilst the majority of pharmaceutical drug products remain conventional, small-molecule medicines; the …

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