Validation and Compliance

Feb 18, 2014
By BioPharm International Editors
Thirteen companies are accepted for participation in the supply chain program.
Dec 01, 2013
BioPharm International
The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.
Dec 01, 2013
BioPharm International
The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).
Nov 01, 2013
BioPharm International
By BioPharm International Editors
The authors discuss how to develop a cost-effective thermally protective packaging system.
Nov 01, 2013
BioPharm International
By BioPharm International Editors
USP is developing and revising distribution standards in response to changes in the global supply chain.
Nov 01, 2013
BioPharm International
By BioPharm International Editors
BioPharm International speaks with industry experts about challenges faced in managing the cold chain.
Nov 01, 2013
By BioPharm International Editors
A new report details FDA's role and responsibilities in personalized medicine.
Nov 01, 2013
FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.
Sep 30, 2013
By BioPharm International Editors
FDA publishes guidance on ANDA submissions.
Sep 17, 2013
By BioPharm International Editors
EMA releases details of restructuring.
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