A life science company dedicated to accelerating drug and device development. Your trusted advisor in regulatory, GXP quality, auditing, clinical, IRB services
Indianapolis, IN
Joined January 2016
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The riskier the study, the more rigorous the human subject protections required by the #IRB. Our IRB Chair discusses the different levels of risk and the several #regulations that must be considered when reviewing a study. wp.me/p92tF6-1XN
New blog: The simple, powerful question that drug and medical device developers should ask their #regulatory consultant - wp.me/p8RFUE-1oD
As organizations start to implement their response to the spread of COVID-19, it is likely that human subjects research will be affected. Read the Pearl IRB COVID-19 response on our blog: wp.me/p92tF6-1VY #COVID19 #humansubjects #clinicalresearch
Day #2 of MD&M West is underway in beautiful Anaheim! Our team is looking forward to another full day of networking with life science and medical design/manufacturing professionals. #AdvMfgExpo
Gretchen Bowker, CEO of Pearl Pathways, speaks about the major regulatory issues and trends set to impact the industry in 2020 (and beyond) at the @IHIF1 #LifeSciencesLunch. @BTLawNews
Hearing from @PearlPathways CEO Gretchen Bowker, @btpidgeon with Vision Tech, Deborah Pollack-Milgate with @BTLawNews and Kristin Jones with @IHIF1 on what’s ahead in 2020 for the life sciences industry at the December Life Sciences Lunch. – at Indianapolis, IN
"What to do in Those 'Oh No' Moments: You’ve Just Been Handed an FDA 483." Learn practical steps to upon receiving a 483 from an FDA inspection in a new blog from one of our Senior Advisors/former FDA Reviewer: wp.me/p8RFUE-1nK #FDA #regulatory #qualitycomplaince
OHRP issues exception related to single IRB review requirements for collaborative research -- "Determination of Exception for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements" bit.ly/2XAQGpO #CommonRule #IRB
How do you prepare for a scheduled (or unscheduled) visit from regulatory agency inspectors? We provide tips on what to do when the inspectors arrive at your facility in a new blog, "What to Do During those 'Oh No' Moments..." wp.me/p8RFUE-1ny #FDA #regulatory #audit
