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Tag Archives: nonclinical research
Vendor Selection – All that Glitters is Not Gold
One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities. Several variables determine what makes a good outsourcing partner – … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged biotech, clinical trials, CMC, CROs, drug development, funding, IND, manufacturing, nonclinical research, outsourcing, pre-IND, regulatory affairs
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Annual Reports: A Time for Reflection
You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year? Quite possibly. In the rush to keep things moving, it’s all too easy to not take the time … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged 21 CFR, adverse events, annual report, clinical trials, CMC, drug development, eCTD, FDA, IND, nonclinical research, protocol
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July 2010 FDA Guidances
Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in July 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA, Regulatory Strategy
Tagged cardiovascular, FDA, guidance, ICH, IND, medical devices, nonclinical research, transdermal
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Webinar Slides – Nonclinical Drug Development
Yesterday, Cato Research hosted a webinar titled, “Nonclinical Drug Development – A Successful Path Forward.” Senior Toxicologist Sharon Daily, Ph.D. gave a very informative presentation that was followed by some great questions from the audience. As promised, the slides from … Continue reading
Give Your Scientists an Edge – Partner with a CRO!
Image via Wikipedia In the fast paced R&D world, every biotech is looking for an edge to keep them ahead of their competitors and to help them achieve their goal of either getting a drug to human clinical trials or … Continue reading
Posted in Regulatory Strategy, Venture Capital
Tagged biotech, clinical trials, drug development, nonclinical research, outsourcing, venture capital
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