PROJECTS
Cerneos Group develops and implements regulatory strategies, manages projects and prepares submissions for biologics, medical devices and drugs.
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IND, ANDA and BLA
submissions for small molecule and biologic products
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CMC preparation
for BLA and NDA projects
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Microfluidic assay development
for remote blood testing
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Regulatory submissions
management with FDA
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Briefing Book development
for Type A, B, C meetings with FDA
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Fundraising and Grant Proposal Development
for early stage biotech, medical software and medical device ventures
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Grant proposals
for vaccine therapeutic
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Telemedicine solutions
for home exams
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Reviewing product labeling
and marketing materials for drug products