Regulation and Compliance - BioPharm International

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Regulation and Compliance

Should Regulation of Combination Products Become More Centralized in Europe?

May 1, 2013

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Extractables and Leachables: Best Practices to Ensure Patient Safety

May 1, 2013

The author presents best practices for extractables and leachables.

Regulatory Convergence Sought for Global Pharma Market

May 1, 2013

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

State of Quality and Compliance in the Biopharmaceutical Industry

April 1, 2013

Have FDA initiatives improved manufacturing quality?

Navigating Emerging Markets — Latin America

April 1, 2013

Latin America's diverse growing market seeks regulatory harmonization.

Advancing QbD in the EU

April 1, 2013

EU authorities are stepping up their efforts to incorporate QbD principles.

Manufacturers Under Pressure to Manage Painkillers

April 1, 2013

Opioid abuse generates calls for efforts to curb distribution.

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.

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