Seeking Experts To Work On FDA Projects

We require an IRB Chairman expert to provide a written report (and perhaps court testimony) that specifies the obligations of a IRB Chairman when confronted with FDA clinical trial regulatory violations. This is a whistle-blower case in which the IRB Chair was wrongly fired after reporting to his Sponsor that FDA regulations were violated because a published clinical trial was conducted without an IRB-approved protocol or informed consent. The study used varying doses of testosterone in women with migraines. Those doses were adjusted by a Ukrainian doctor that was not licensed to practice……more

I am looking for Class 1 FDA device need assistance in filing necessary paperwork and FDA registration….more

Gastroenterology Clinical Trials

I am searching for an independent consultant with experience in managing clinical trails specific to gastroenterology. Prior FDA experienc is highly desired. This is remote work with little travel expected…….more

FDA Medical Device

*******, a class 3 medical device startup company is looking for and experienced Chief Operating Officer with experience of taking a medical device from startup to FDA approval…….more

 

 

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