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FDA Inspection – A Survival Guide
Tutela Monitoring Systems LLC
While the FDA are the regulatory body, there is actually no legal requirement to respond to a Form 483 inspection report. According to the FDA’s own website, a form 483 report records “inspectional observations, and do not represent a final agency determination regarding your compliance.” It all sounds quite benign, but the consequences and ramifications can be serious and a timely, proper, ...
 
Cell Therapy Logistics_Beyond the basics
Fisher BioServices
My previous eBook, Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield, and several of my blogs, have discussed the basics of building a successful logistics strategy for the management of cell-based material. If you read these, then you are aware of the better-known and important factors to consider, such as:
 
Physician Access
SK&A, A Cegedim Company
U.S. Physicians' Availability to See Pharmaceutical Company Sales Representatives. Statistical report reveals "see and no-see" physicians and their appointment requirements for visits by industry sales professionals. Data is segmented by Practice Specialty, by State and Region; by Office Size; by Practice Size; by Daily Patient Volume; and by Practice Ownership. Updated 2013.
 
Non-Steroroidal Cyclooxygenase (COX) Inhibitors
EMD Millipore Bioscience
Cyclooxygenases (COXs), also known as prostaglandin H synthases, are fatty acid oxygenases that contain about 600 amino acid residues and act on arachidonic acid to generate prostaglandins (PG). All vertebrates contain two COX genes: one encoding the constitutive COX-1 and another inducible COX-2. COX-1 and COX-2 share approximately 60-65% amino acid identity. These COX isoforms are bifunctional ...
 
IHC General Protocols
United States Biological
Immunohistochemistry is widely used in basic research to understand the distribution and localization of biomarkers and differentially expressed proteins in different parts of a biological tissue. IHC staining is also widely used in the diagnosis of abnormal cells such as those found in cancerous tumors. Visualizing an antibody-antigen interaction can be accomplished in a number of ways. In the ...
 
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Jackson Laboratory's legacy of genetic discovery The Jackson Laboratory The Jackson Laboratory has been a significant force in genetic discovery for more than 80 years. We discover the genetic basis for preventing, treating ...
 
Tutela Wireless Temperature Monitoring Tutela Monitoring Systems LLC Tutela wireless temperature monitoring systems are fully FDA compliant, deliver unparalleled accuracy, and rock-solid audit trails for complete regulatory ...
 

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Tutela Monitoring Systems LLC Pharmaceuticals
Fujirebio Europe (formerly Innogenetics) Pharmaceuticals
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