Results

Case Studies

Real programs we staffed and delivered across pharmaceutical, biotech, and medical device work. What the client needed, what we did, and how it turned out.

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Biologics CMC Analytical Dev. Consultant

Phase III biologics analytical development support with LCMS expertise and new CRO relationships.

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Case study

Manufacturing, Quality and Process Team

Recommissioning and qualifying a manufacturing site to produce COVID-19 test kits at scale.

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Biologics CMC PIP

CMC and quality oversight for a Phase III monoclonal antibody program at a CMO.

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Case study

Phase III Biologic, Sickle Cell Disease (SCD)

A team of 20 consultants supporting BLA preparation and commercialization for a sickle cell biologic.

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Case study

DHF Remediation Support for Class I Medical Devices

Urgent Design History File remediation to meet EU MDR requirements for Class I medical devices.

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Case study

Design and Development Support for Abbott's Cardiovascular Division

Mechanical engineering and CAD support for stents, guidewires, and cardiovascular device development.

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Case study

Design and Development Support for Abbott's Cardiovascular Division II

Validation and engineering support for cardiopulmonary device design and development.

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