Search results for " enterprise" in Articles / App Notes
Article
Global Expansion Shapes Drug Oversight
Numerous API samples are falsified or substandard, according to research by the American Enterprise Institute. Alan Coukell of The Pew Charitable Trusts described rising concern over reliance on Chine…
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Bureaucratic Roadblocks Threaten Biopharma Growth
Indeed, the vast majority of biotechnology companies are small- and medium-sized enterprises. What these companies share is a philosophy that is crucial to the task of developing biotechnology product…
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EMA Collaborates with HTA Assessment Networks
The move has been welcomed by small- and medium-sized enterprises (SMEs), especially those developing advanced medicines. “SMEs are generally interested in receiving joint EMA/HTA advice, in particula…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Eugene Corretge, speaking on behalf of European Biopharmaceutical Enterprises (EBE), representing both makers of original biologics and biosimilars, said that the revised guideline was unclear about w…
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Supplier-Change Management for Drug-Product Manufacturers
This evaluation usually involves a search of the enterprise resource planning (ERP) system and production documentation (e.g., specifications, standard operating procedures [SOPs], test methods) to de…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…