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In the News

Greater Wilmington Business Journal (January 2018)

PPD Partners With UK Firm To Speed Pediatric Drug Development

Karen Kaucic explains that the new program was established in response to increasing customer demand, as well the drive by regulatory agencies to promote the development of new medicines for children.

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Outsourcing-Pharma (January 2018)

PPD, Quotient to support entire pediatric program through single contract

Karen Kaucic announces a new collaboration to accelerate pediatric drug development.

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BioPharm International (December 2017)

Single-Use Bioreactors Pose E&L Challenges

Derek Wood comments on the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.

BioPharm International
Regulatory Focus (November 2017)

A New Regulatory Paradigm for Medical Devices in India

Vibhu Yadav, Dushyant Kumar and Nancy Mathewson outlines medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

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Regulatory Focus (November 2017)

The Medical Device Coordination Group: A New Authority Under EU Device Regulations

This article by Robert Cumming and Nancy Mathewson discusses the organization and functions of the Medical Device Coordination Group established under the new EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.

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Pharmaceutical Outsourcing (November 2017)

Analytical Testing – Extractables and Leachables Testing for Pharmaceutical Products

Xiaochun Yu and Derek Wood provide a detailed overview of extractables and leachables.

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Applied Clinical Trials (November 2017)

The Virtual Opportunity in Rare Disease Trials

In this article written by Karen Kaucic, Horacio Plotkin and Christopher Komelasky, the authors discuss how rare disease research can be solved with virtual trials and their supporting technologies.

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Regulatory Rapporteur (November 2017)

Marketing applications for biopharmaceuticals: Considerations for different jurisdictions – Part 2

In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.

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PharmaVOICE (November 2017)

2017 year in preview: Trends revisited

Jai Balkissoon, M.D., and Elizabeth Madichie offer their thoughts one year later on the Cancer Moonshot and combination therapies, two of the key trends PharmaVOICE identified for 2017.

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