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How the FDA Sped Up Cancer Product Development and Reviews During a Global Pandemic

Amid the ongoing COVID-19 public health emergency, the US Food and Drug Administration (FDA) has emphasised the importance of caring for patients with established conditions …

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How to Streamline a Complex Process: The Value Add of Experienced Medical Writers for Oncology Dossiers

Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, the majority of new drugs approved by the …

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Achieving Simultaneous New Drug Document Submission for the FDA and EMA

International Conference on Harmonization (ICH) guidance makes it feasible to construct a new drug submission dossier that can be used for applications to multiple countries. …

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Turning Pharmacovigilance into a Strategic Advantage

Safety science complexity is on the rise as the volume of safety data explodes (case volumes are growing at a pace of 15 to 20% …

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Current features

Why Do We Need Patient Diversity in Clinical Trials?

Ensuring Drug Safety, First and Foremost, Even Ahead of Drug Efficacy In the commercialisation of new medications, the paramount legal responsibilities of the pharmaceutical company …

Continue Reading →

Current Edition

Current Features

Current Features

Current features

How the FDA Sped Up Cancer Product Development and Reviews During a Global Pandemic

Amid the ongoing COVID-19 public health emergency, the US Food and Drug Administration (FDA) has emphasised the importance of caring for patients with established conditions – particularly for …

Read More →
Current features

How to Streamline a Complex Process: The Value Add of Experienced Medical Writers for Oncology Dossiers

Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, the majority of new drugs approved by the FDA were cancer …

Read More →
Current features

Achieving Simultaneous New Drug Document Submission for the FDA and EMA

International Conference on Harmonization (ICH) guidance makes it feasible to construct a new drug submission dossier that can be used for applications to multiple countries. Two of the …

Read More →
Current features

Turning Pharmacovigilance into a Strategic Advantage

Safety science complexity is on the rise as the volume of safety data explodes (case volumes are growing at a pace of 15 to 20% per year),1 regulatory …

Read More →
Current features

Why Do We Need Patient Diversity in Clinical Trials?

Ensuring Drug Safety, First and Foremost, Even Ahead of Drug Efficacy In the commercialisation of new medications, the paramount legal responsibilities of the pharmaceutical company are, firstly, to …

Read More →
Current features

Improving Health Literacy to Transform Clinical Trials

The healthcare industry struggles with resolving fundamental patient communication challenges. Approximately 50% of adults cannot read at a high school level and 88% of adults are not proficient …

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Company Profiles

PCI PHARMA SERVICES

PCI is a leading global CDMO, truly spanning the cycle, connecting development and commercialization, de-risking the supply chain providing clients with integrated end-to-end drug development, …

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Tower Cold Chain

Tower Cold Chain is a leading provider of temperature-controlled solutions to the global pharmaceutical, biotech and life-science industries. Working with businesses since 2007 to protect …

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D.W.L

Since 1962, Dora Wirth Languages (DWL) has been providing global translation services to the life science industry. From international pharmaceutical companies to academia and to …

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MLM Medical Labs GmbH

MLM Medical Labs GmbH

MLM Medical Labs (MLM) is a Central Laboratory dedicated exclusively to clinical trials. MLM offers full laboratory services, including a whole range of analytics: standard …

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Ramus Medical Ltd

Ramus Medical Ltd

Ramus Corporate Group is a union between Ramus Medical and Medical Diagnostic Laboratory Ramus. Ramus Medical is a full service Contract Research Organization based in …

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Trilogy Writing & Consulting

Trilogy Writing & Consulting

Meet the Masters of Medical Writing At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is …

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