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  • All Posts
  • Blog
  • Events
  • News
  • QbDVision
  • Thought Leadership
News

Welcome John Maguire and Hello Boston!

We’re pleased to welcome aboard and introduce John Maguire as our new Director of Client Services. Joining us from Takeda in Lexington, MA, John comes with a deep background in biomanufacturing processes and the application of operational technologies to optimize these processes.

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Blog

RIP: Spreadsheets and Fishbones

The industry is still married to spreadsheets and fishbone diagrams for risk assessment and for understanding cause-and-effect relationships between process and product requirements. Here’s why those tools may no longer be sufficient.

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Blog

The Paradigm of Pharma Manufacturing is Shifting

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 …

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Blog

Early Discipline in Biotech/Pharma Startups

In the context of product lifecycle management in the pharmaceutical and biotech industries, the discipline of scientific rigor is critical. Here’s why.

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News

Exemplar Compliance and CherryCircle Form Strategic Relationship to Promote Industry Adoption of QbD

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.

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Blog

Unstructured vs. Structured Data

The discussions around “unstructured data” vs. “structured data” in the context of pharmaceutical submissions have begun in earnest. Catch up with the debate.

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Blog

QbD is more than just DOE…a lot more

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.

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Blog

Has eCTD outlived its usefulness?

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.

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Blog

What’s a TPP?

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.

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Harness your expertise

See how QbDVision can help you leverage your team’s know-how to accelerate drug development.