Scientific and Regulatory Writing

Aclairo’s regulatory and scientific writers have extensive experience in researching and writing regulatory documents and position papers.  We focus on the big picture while being attuned to the details. We will work with you to meet your specifications and timelines using your templates and style guide, or our own, to create submission-ready documents. We follow SOPs to ensure consistently high quality documents and conduct a quality control (QC) review of each document. Our regulatory writing services include:

  • Regulatory Submissions
    • Regulatory applications for the FDA and Europe
    • Special Protocol Assessments (SPAs)
    • Investigator Brochures (IBs)
    • Legacy or eCTD formats
    • INDs, CTDs, BLAs and NDAs
    • Technical and scientific review and QC checks of regulatory applications
  • Primary research manuscripts, position papers and white papers for preclinical, DMPK, and clinical research publications
  • Literature reviews and summaries
  • Subject-specific literature searches
  • GLP study reports
  • Quality control review of each document
  • FDA meeting packages

For more information, please contact: Hilary Sheevers