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Malia Lewin Brings It to CherryCircle!

CherryCircle Software, Inc. announced today that Malia Lewin has joined its executive management team as Chief Business Officer. CherryCircle has developed the QbDVision® software platform.

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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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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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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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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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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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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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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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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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Harness your expertise

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