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Modern medicine is stepping into an exciting and promising renaissance with a wave of small-batch cell, gene and curative therapies receiving regulatory approvals. Sixteen months …
In the context of product lifecycle management in the pharmaceutical and biotech industries, the discipline of scientific rigor is critical. Here’s why.
WE’re proud to announce a new relationship to accelerate the pharmaceutical industry’s adoption of Pharma 4.0, utilizing the best practices of Quality-by-Design (QbD) and Data Integrity-by-Design.
The discussions around “unstructured data” vs. “structured data” in the context of pharmaceutical submissions have begun in earnest. Catch up with the debate.
As I talk to people about managing process development activities under a Quality-by-Design framework (QbD), people equate Quality-by-Design (QbD) with Design of Experiments (DOE). There are important differences.
The eCTD format provides large amounts of unstructured text in PDF format which leads to lengthy and redundant reviews because the key information is buried in the documents.
The TPP is a dynamic summary that changes as knowledge of the drug increases from preclinical and clinical studies. Learn more about this critical tool.
Pat Sacco is a Biotechnology Technical Operations Executive with extensive experience in leading and managing technical operations functions, within the biotech and life sciences industries.
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