A life science company dedicated to accelerating drug and device development. Your trusted advisor in regulatory, GXP quality, auditing, clinical, IRB services
Joined January 2016
- Tweets 1,251
- Following 774
- Followers 432
- Likes 504
363 Photos and videos
As part of Versiti’s continued growth, we’re excited to announce the acquisition of Pearl Pathways, a trusted advisor and preferred partner for enabling innovative and expedited life science product development. bit.ly/3FPeLAc
2
5
256
5 Apr 2021
This authorization marks an important step, not only in the fight against COVID-19, but also creating a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway. wp.me/p8RFUE-1sv
15 Mar 2021
15 Mar 2021
"Pre-Clinical Pathways: Start Off On the Right Foot" - One of Pearl Pathways' Senior Advisors will speak during the Indiana Health Industry Forum (IHIF) Life Sciences Lunch webinar on Tuesday, March 16. Event info and registration: wp.me/p8RFUE-1s9
1
1
9 Feb 2021
In response to the Covid-19 Public Health Emergency, the U.S. #FDA permanently exempted seven Class I device types from #510k premarket notification requirements. FDA also proposed similar exemptions for 83 Class II devices and one unclassified device. wp.me/p8RFUE-1ry
2 Dec 2020
Pearl IRB Co-chair, Gretchen Parker, will be covering the 2020 Advancing Ethical Research Conference as part of the #AER20 Blog Squad! Tune in to the virtual conference over three weeks, Dec. 1-2, 8-9, and 15-16. bit.ly/3lxTDS9 @primrconnect
3
12 Nov 2020
Pearl Pathways is speaking during the "Digital Health: Telemedicine and Virtual Clinical Trials" virtual conference, Nov 12-13. The event is part of the IU Center for the Business of Life Sciences Conference Series. See the full agenda here: bit.ly/3lql6WT #DigitalHealth
19 Jun 2020
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
9 Apr 2020
OHRP issues Guidance for application of the human subjects protection regulations to actions taken in response to the COVID-19 pandemic - lnkd.in/gPXtxzR
1
20 Mar 2020
New blog: The simple, powerful question that drug and medical device developers should ask their #regulatory consultant - wp.me/p8RFUE-1oD
12 Mar 2020
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
1
1
11 Mar 2020
“Some drug and device companies could run into problems as they seek Food and Drug Administration approval for their products after the agency moved to suspend inspections of foreign manufacturing plants through next month...” - bit.ly/2vY0xMX - via @medcitynews
2 Mar 2020
"Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data" - bit.ly/2VEixq0 - via @statnews
Pearl Pathways retweeted
FDA Speeds New Coronavirus Diagnostic Tests | #Regulatory Focus ift.tt/2I9ybld
1
2
Pearl Pathways retweeted
18 Feb 2020
Updated: Striking While the Iron is Hot: New NDA, BLA Filings Spike in Q1 of FY 2020 | #Regulatory Focus ift.tt/2SkmFbF
1
2
17 Feb 2020
Pearl Pathways is looking forward to attending and speaking at the RAPS Euro Convergence this year in Brussels. #lifesciences #regulatoryaffairs #EUMDR
14 Feb 2020
With EU Medical Device Regulation Deadline Looming, Regulatory Pros to Gather in Brussels for RAPS Euro Convergence | #Regulatory Focus ift.tt/38FkoOU
2
12 Feb 2020
The Pearl team enjoyed some right-brain fun this afternoon for our company outing! 🎨
2
12 Feb 2020
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
Pearl Pathways retweeted
23 Jan 2020
Drug-Drug Interactions: FDA Issues Guidance on Clinical, In Vitro Studies | #Regulatory Focus ift.tt/2TRkAWN
2
1
17 Dec 2019
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
1
2
7