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They leverage us for Growth, Process Improvements and Organization Development.
Background in regulatory medical writing (MW) and drug product development, with a strong publication record—an unusual combination of MW expertise, analytical skills, management experience, medical knowledge. Experienced in all phases of drug, biologic, and medical device products:
• ICH-compliant regulatory submissions (INDs, NDAs, sNDAs, BLAs, sBLAs, 6 eCTDs, and 2 combination drug/device submissions), clinical study protocols, amendments, clinical study reports Read more
Typical consulting project includes supervision of writers and/or generating documents for submissions to regulatory agencies (eg, FDA). Documents include, but are not limited to, INDs, NDAs, sNDAs, and sBLAs (all in eCTD format); CSRs, IBs; clinical study protocols and amendments; briefing packages; EOP meeting preparation; pharmacology and toxicology reports; CMC documentation; PowerPoint slide preparation; biomedical manuscripts, posters, abstracts, and oral presentations.
Partial list of clients includes:
• Pfizer, Inc.
• Puma Biotechology
• Juno Therapeutics, Inc.
• Gilead Read more