Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

EMA finalizes guidance on process validation for manufacturers

Posted on | March 5, 2014 | Comments Off

“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

Posted on | February 12, 2014 | Comments Off

“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 makes pharmaceuticals, chemicals and laboratory equipment. The company More…

Regulatory Compliance for Spreadsheets

Posted on | January 30, 2014 | Comments Off

“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 risks, improves business performance, and reduces cost from manual, tedious and error-prone processes while helping to ensure Part 11 compliance. To register for this complimentary webinar click here.

Government Shutdown Hinders Biomedical Research

Posted on | October 16, 2013 | Comments Off

“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 have been closed and workers have been furloughed without pay until a decision can be reached.1 The government shutdown is affecting every walk of life with closures from National Parks to the Centers for Disease Control. If an agreement on the budget is not reached soon, the US debt will default with possibly disastrous consequences to the US economy… more

Insight: Big Pharma braces for retirement of favorite regulator

Posted on | October 11, 2013 | Comments Off

“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

Posted on | August 8, 2013 | Comments Off

logo-5d30dcbb13cf88695252873c6a73d2c6“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, is a powerful relationship management system that enables NCI scientists to work efficiently with an extended global network of internal and external research partners…more

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