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Tag Archives: GLP
Project Management for Biotech Companies
In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading
Posted in Clinical Trials, Project Management, Regulatory Strategy
Tagged biotech, Cato Research, central labs, clinical investigator, clinical research, clinical trials, CMC, CROs, drug development, drug product, efficacy, enrollment, FDA, GCP, GLP, GMP, ICH, manufacturing, nonclinical research, project management, protocol, safety, site selection, SOP, stability, toxicology
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Guidance for the Therapeutic Discovery Tax Credit
Credit you give yourself is not worth having. – Irving Thalberg For all you virtual biotechs and small start-up biotechs that survived the “Great Recession,” here is something to look forward to. I’ve mentioned the Therapeutic Discovery Tax Credit before, … Continue reading
Posted in Industry News
Tagged biomedical, biotech, CMC, FDA, GLP, IRS, Phase 1, Phase 2, pre-IND, tax credit
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