ICH working to clarify Q7 for regulators
The ICH says regulator uncertainty over Q7 for ingredient supply chains, contractor management and quality management systems must be resolved.
Archives for November 13, 2012
Elder Pharma wants to make pile from EU Diosmin API sales
Elder Pharma hopes to increase sales to European drugmakers after receiving a certificate of suitability (CEP) for the API Diosmin.
SNBL USA gets FDA ‘close out’ letter for Everett animal testing lab
SNBL USA says some customers’ regulatory departments were put off by 2010 warning but that FDA ‘close out’ letter will open doors to new business.
India's CDSCO wants quicker drug recalls
The Indian CDSCO wants drug companies to withdraw defective drugs faster and to practice for such recalls.
Report from PCT Europe
SMEs are second best in partnerships with big CROs, says PCT panel
Small to mid-sized pharmas are often overlooked by CROs to focus more on larger clients, according to a PCT panel.
EXCLUSIVE
Symbiosis hunts US clients looking to run trials in EU
Symbiosis has opened a new US office in a bid to attract American clients looking to run trials in Europe.