MEDICAL & REGULATORY WRITING

Our group can provide support with:

• • ​Drafting peer review publication-targeting manuscripts, abstracts & presentation slide decks.

• • Regulatory writing for
    Therapeutics: INDs (eCTD modules 2.4 – 2.7, 4.0), IBs, DSURs, CSRs, Phase 1-3 clinical trial protocols, amendments, updates, and 505b2s.
    Medical Devices:  510Ks & De Novo applications.

• • Quality Assurance/Quality Control

• • Grant writing: R01, R22, SBIR/STTR

• • Government contract writing
  • Copy for promotional & professional education material