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Background

MEDICAL & REGULATORY WRITING

Our group can provide support with:

    • ​Drafting peer review publication-targeting manuscripts, abstracts & presentation slide decks.
    • Regulatory writing for INDs (eCTD modules 2.4 – 2.7, 4.0), IBs, DSURs, CSRs, Phase 1-3 clinical trial protocols, amendments, updates, and 505b2s.
    • Quality Assurance/Quality Control
    • Grant writing: R-series, SBIR/STTR
    • Government contract writing
    • Copy for promotional & professional education material