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Posted On: 08/30/2021 1:37:35 PM
Post# of 145872
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Not sure if this has been posted here. This is from Jesus, on YMB:
Chris Recknor mentioned we are working with Dunn Regulatory:
“ Our expert consultants are US and EU strategists, who have a proven track record of resolving even the most complex regulatory situations. We can:
-Develop pragmatic approaches to regulatory challenges
-Develop concise and thorough regulatory strategies
-Lead regulatory meetings and meeting package preparation
-Resolve complex pharmacology/toxicology, clinical or CMC regulatory issues
-Write, manage, and review all modules of the common technical document (eCTD) from IND to BLA or NDA
Negotiate with the FDA and EMA
-Strategically determine product placement
-Serve as your US Agent
Leverage expedited regulatory pathways
-Prepare Integrated Development Plans
Prepare Orphan Drug, Breakthrough Therapy, and Fast Track applications
-Perform Due Diligence
-Electronic Publishing Services (through the ESG)
Different statistical groups and neurological reporting
In result:
“We are discovering things about this molecule that weren’t discovered previously.” -Scott Kelly
Chris Recknor mentioned we are working with Dunn Regulatory:
“ Our expert consultants are US and EU strategists, who have a proven track record of resolving even the most complex regulatory situations. We can:
-Develop pragmatic approaches to regulatory challenges
-Develop concise and thorough regulatory strategies
-Lead regulatory meetings and meeting package preparation
-Resolve complex pharmacology/toxicology, clinical or CMC regulatory issues
-Write, manage, and review all modules of the common technical document (eCTD) from IND to BLA or NDA
Negotiate with the FDA and EMA
-Strategically determine product placement
-Serve as your US Agent
Leverage expedited regulatory pathways
-Prepare Integrated Development Plans
Prepare Orphan Drug, Breakthrough Therapy, and Fast Track applications
-Perform Due Diligence
-Electronic Publishing Services (through the ESG)
Different statistical groups and neurological reporting
In result:
“We are discovering things about this molecule that weren’t discovered previously.” -Scott Kelly
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