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Our Editors and Advisory Team

Experienced professionals with manufacturing, quality assurance and regulatory affairs expertise in pharmaceuticals and medical devices.

Jamie is a private equity investor with operating experience leading teams in highly regulated industries including pharmaceuticals, medical devices, and aerospace.

Jamie Schleck

Investor and Adviser

Dina Kisver has operating experience as Vice President of Quality for a manufacturer of active pharmaceutical ingredients. She holds an MS degree in Quality Assurance and Regulatory Affairs from Temple University.

Dina Kisver

President and Chief Editor

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FDA cited a firm for resuming sterile filling after a 5-week shutdown without conducting a […]

An alarming and recent 483 highlights FDA’s continued scrutiny of data integrity issues concerning the […]

In most compliance training programs, employees are taught what to do: follow SOPs, complete forms, […]