Delivered By DeGrazio
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Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
7/29/2024
Regulatory guidance and standards, in official documentation, tend to emerge at a slower pace than do industry best practices. In Part1 of a two-part series, Fran DeGrazio explains why biopharma companies should build and apply best practices in advance of official regulations regarding drug product quality.
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Embrace Packaging and Delivery Systems Designed for Today's Standards
7/1/2024
Regulations and standards for drug delivery systems and packaging are ever evolving and expanding, making it harder and more costly for older products to meet them. In this article, Fran DeGrazio explains why it is imperative that pharma companies consider new product adoption.
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The Key to Regulatory Innovation? Global Harmonization
6/4/2024
Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices.
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Organizational Imperatives For Combination Product Development
4/18/2024
Developers of combination products must address varied and numerous regulatory stipulations and considerations. In this article, drug delivery industry veteran Fran DeGrazio offers recommendations for how to do so efficiently and effectively.