Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

EMA finalizes guidance on process validation for manufacturers

“The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site… more“

A Tale of Two Mercks

“Activists gathered with signs outside Merck’s East London offices last week, protesting the drugmaker’s involvement in a campaign to delay South Africa’s proposal to allow low-cost copies of patented drugs. The only problem: The group STOPAIDS targeted the wrong Merck. The protesters were at the offices of Merck KGaA (MRK), a Darmstadt, Germany-based company that […]

Regulatory Compliance for Spreadsheets

“CIMCON will host a complimentary webinar to discuss Regulatory Compliance for Spreadsheets on Thursday, February 6th at 10:00 AM EST. Business and Compliance Risks from use of uncontrolled spreadsheets are well publicized and documented by FDA warnings and sanctions. The eInfotree Excel software from CIMCON provides enabling technology to implement a process that eliminates these […]

Government Shutdown Hinders Biomedical Research

“Amidst the many challenges facing the life sciences industry today such as diminishing funding sources, increased costs to develop new drugs and products and major pharmaceutical patents expiring, a government shutdown has occurred leaving scientists in the lurch. Lawmakers are in a standstill as they disagree over the 2014 budget. Government-funded organizations around the country […]

Insight: Big Pharma braces for retirement of favorite regulator

“The retirement of Dr. Janet Woodcock as head of the Food and Drug Administration’s pharmaceutical division is at least a year away, but already the industry she regulates is worrying about who will replace her.…more“

Assay Depot Creates Medical Research Exchange with the National Cancer Institute

“Assay Depot, the pharmaceutical industry’s leading marketplace for scientific services, today announced the creation and launch of the ‘Center for Cancer Research’ Exchange (CREx) – an online medical Research Exchange developed in partnership with the Center for Cancer Research (CCR), an Intramural Division of the National Cancer Institute (NCI). CREx, an Assay Depot Enterprise Solution, […]

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