“Naresh has become an essential part of Spectrum by preparing multiple regulatory filings ranging from annual reports (both small molecule NDAs and monoclonal BLAs) to CMC supplemental applications to briefing documents for meetings with the FDA. His technical background allows him to evaluate scientific data with a critical eye while at the same time preparing e-documents that are consistent with FDA regulations and expectations. Naresh has integrated seamlessly with both the regulatory team and the CMC technical teams at Spectrum. He is professional at all times and focuses developing and expanding our drug product portfolio without distraction. I highly recommend Naresh for any CMC Regulatory position or consulting.”
San Diego, California, United States
Contact Info
887 followers
500+ connections
San Diego, California, United States
Contact Info
887 followers
500+ connections
About
•Member, Management Team and experienced regulatory affairs leader with broad experience…
Activity
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We're proud to welcome Arlene Kray, PharmD, Ph.D., to Avenzo as our Director of Medical Writing. Arlene has extensive experience leading global…
We're proud to welcome Arlene Kray, PharmD, Ph.D., to Avenzo as our Director of Medical Writing. Arlene has extensive experience leading global…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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BREAKING: #FDA Approves Repotrectinib in NTRK-Positive Solid Tumors! The approval is supported by findings from the registrational phase 1/2…
BREAKING: #FDA Approves Repotrectinib in NTRK-Positive Solid Tumors! The approval is supported by findings from the registrational phase 1/2…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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I am excited to share that my research article "Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products…
I am excited to share that my research article "Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products…
Liked by Naresh Nayyar (PhD, RAC, MBA)
Experience & Education
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Avenzo Therapeutics
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We are excited to introduce Denise (Leone) Trone, our new Executive Director, Biometrics at Avenzo Therapeutics. She brings more than 25 years of…
We are excited to introduce Denise (Leone) Trone, our new Executive Director, Biometrics at Avenzo Therapeutics. She brings more than 25 years of…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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Congratulations to Prof. Eric Jacobsen of Harvard University on receiving the 2024 Willard Gibbs Award! Thanks to Sharada Buddha, Anita Mehta, Vivian…
Congratulations to Prof. Eric Jacobsen of Harvard University on receiving the 2024 Willard Gibbs Award! Thanks to Sharada Buddha, Anita Mehta, Vivian…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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BIOTECH NEWS: Wugen announced RMAT and PRIME designations to accelerate regulatory reviews for its investigational, off-the-shelf allogeneic CAR-T…
BIOTECH NEWS: Wugen announced RMAT and PRIME designations to accelerate regulatory reviews for its investigational, off-the-shelf allogeneic CAR-T…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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Great session today @AAPSComms #NBC2024. Still have questions about our ENHANZE platform to enable rapid, large volume subcutaneous injections with…
Great session today @AAPSComms #NBC2024. Still have questions about our ENHANZE platform to enable rapid, large volume subcutaneous injections with…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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I am honored and humbled to announce that today I was elected as a Fellow of the Faculty of Pharmaceutical Medicine in the United Kingdom. This is a…
I am honored and humbled to announce that today I was elected as a Fellow of the Faculty of Pharmaceutical Medicine in the United Kingdom. This is a…
Liked by Naresh Nayyar (PhD, RAC, MBA)
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