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Milestones and Moderate Progress in 2012 Drug Approvals

April 1, 2013

First gene therapy and plant-based expression vector products approved in 2012.

Navigating Emerging Markets — Latin America

April 1, 2013

Latin America's diverse growing market seeks regulatory harmonization.

Achieving More Effective and Efficient GMP Auditing

March 2, 2013

The authors present solutions based on a review of current service offerings and their audit experience.

Quality and Regulatory Leadership: Right-Sizing Need and Cost

March 2, 2013

This article examines the options to best match needs and spending for quality and regulatory leadership.

CROs in a Global State of Mind

March 2, 2013

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.

Managing Contract Manufacturing Organization Relationships

March 2, 2013

Successful management of the CMO/client relationship should include open communication and trust.

Securing the Supply Chain

March 2, 2013

A Q&A with SAFC and BioReliance about sourcing and risk mitigation for raw materials.

Emerging Outsourcing Trends in 2013

March 2, 2013

BioPlan's outsourcing survey gives insight on top activities, budgets, and growth trends in biopharmaceutical outsourcing.

Advances in PAT for Parenteral Drug Manufacturing

March 1, 2013

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

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