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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, ...
Protecting Your Protocol Operating a Flawless Clinical Agent Repository
Fisher BioServices
Managing the distribution of clinical agents for large, multi-site, multi- country clinical trials requires a spectrum of expertise and infrastructure, specifically designed to ensure accuracy in order processing and preservation of the integrity of the product from initial receipt into inventory through delivery to the clinical site. These processes are well established for small molecule and ...
United States Biological ELISA General Protocol
United States Biological
The protocols described in this paper are for general application. Any product specific protocol supercedes these general recommendations: •Direct ELISA is suitable for the detection of protein-based antigens can be performed when the desired antibody is available in a conjugated form. •Indirect ELISA is required if the primary antibody is not conjugated. With Indirect ELISA, a conjugated ...
The Scientific Path to Cycle Development
Baxter's BioPharma Solutions business
Management of medication delivery through lyophilization - freeze-drying - is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms. A small but growing number of ...
Managing Scope Creep and Change: A Project Management Perspective Introduction
Adare Pharmaceuticals
When managing the diverse and complex drug development cycle, whether it is discovery of a new molecule or a site transfer for an existing product, it is important for companies to devote the necessary project management resources. These resources are key elements for success in the pharmaceutical industry and include: expertise in strategic pipeline selection, use of standardized project ...
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Tutela Monitoring Systems LLC Pharmaceuticals

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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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The Jackson Laboratory Information
Platinum Press Company
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