THinc . . .  a REGULATORY AND MEDICAL WRITING DEPARTMENT

For clients who need to prepare regulatory, clinical, and scientific documents, we can help you develop and write documents with consistent key messages from concept through completion.

Regulatory Documents

The writers at THinc draw on their extensive knowledge of regulatory agency guidelines to prepare submissions that are compliant with regulations. In addition, we develop strategies to present information in clear and easy-to-follow formats that are amenable to agency reviewers. Regulatory writing projects include

  • IND and NDA submissions (see Regulatory Applications)
  • Clinical summaries and overviews (Sections 2.5 and 2.7 of CTD)
  • Nonclinical summaries, overviews, and tabulations (Sections 2.4 and 2.6 of CTD)
  • CMC summaries and overviews (Section 2.3 and Module 3 of CTD)
  • Integrated summaries of efficacy
  • Integrated summaries of safety
  • Investigational Medicinal Product Dossier (IMPD) clinical, nonclinical, and CMC sections
  • IND annual reports
  • Development safety update reports (DSUR)
  • Regulatory meeting packages
  • Literature reviews
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