Regulatory/GMP Compliance

Nov 16, 2018
Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.
Nov 16, 2018
By Pharmaceutical Technology Editors
Pharma industry welcomes announcement of a draft withdrawal agreement, stating it is an important step towards securing a Brexit deal.
Nov 14, 2018
Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.
Nov 14, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
Nov 12, 2018
Pharmaceutical Technology
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
Nov 09, 2018
By Pharmaceutical Technology Editors
The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
Nov 08, 2018
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
Nov 08, 2018
By Pharmaceutical Technology Editors
Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.
Nov 06, 2018
An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.
Nov 02, 2018
Pharmaceutical Technology
New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.
native1_300x100
lorem ipsum