Modern Drug Commercialization

In today's pharmaceutical market, it often takes more than a decade and an estimated $2.6 billion to bring a new drug to market. The long development lead time result in approximately 7 to 10 year of patent protection before generic competition launches.

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Real Regulatory Ltd

Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance.

OTHER WHITEPAPERS
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Simcyp™ PBPK for Drug-Drug Interactions (DDI)

whitePaper | July 4, 2023

The past two decades have witnessed transformative changes in our approach to using modeling & simulation to assess and manage DDIs. Multidisciplinary innovations in mechanistic assessment of absorption, distribution, metabolism, and excretion (ADME), population pharmacology and pharmacogenetics.

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Manufacturing High-Quality Capsule Products for Pharmaceutical and Nutraceutical Applications

whitePaper | October 25, 2022

To confirm the suitability of empty hard capsules for use in the application of quality-by-design (QbD) in the development and manufacturing of finished pharmaceutical products, the quality target product profile (QTPP) defined by eight critical quality attributes (CQA’s) was examined.

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Asia Pacific – Clinical trial landscape

whitePaper | November 8, 2022

The Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions.

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Redefining the Role of Health Systems as a Specialty Pharmacy Solution for Drug Manufacturers

whitePaper | January 10, 2023

The ideal care model for complex patients is a model in which the entire health care team is made up of experts in the specific disease state being treated. Integrated health care systems and major academic medical centers provide this level of expertise and coordination.

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Access to medicinal products

whitePaper | January 3, 2022

There are many factors that can prevent a patient from being able to obtain the medicine they need, ranging from selective marketing decisions by companies to products being too expensive or pharmacy stock-outs

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Application Notes & Whitepapers 2019

whitePaper | December 19, 2019

Welcome to European Pharmaceutical Review’s Application Notes & Whitepapers Supplement 2019. This year’s topics range from analytical techniques for bioprocess investigation, host cell protein analysis and Raman imaging to advice on outsourcing services for product characterisation.

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Spotlight

Real Regulatory Ltd

Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance.

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