Quality Systems

Apr 03, 2018
By BioPharm International Editors
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
Apr 01, 2018
BioPharm International
More diversified therapies and tighter payer budgets will challenge bio/pharma companies to think outside the industry.
Apr 01, 2018
BioPharm International
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry.
Apr 01, 2018
BioPharm International
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Apr 01, 2018
BioPharm International
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Apr 01, 2018
BioPharm International
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Mar 30, 2018
By BioPharm International Editors
The company’s close communication with customers has enabled it to bring advanced pipetting products to market.
Mar 29, 2018
By BioPharm International Editors
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
Mar 29, 2018
By BioPharm International Editors
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
Mar 29, 2018
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
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