The mission of our regulatory writing team is to author accurate and well-written scientific, medical, and regulatory documents that meet the needs of your target audience (eg, regulatory agencies, scientific journals, scientific meetings, and internal company use).

About Us

What makes regulatory writing at ISI unique is that our writers have strong scientific backgrounds, practical life science experience, and training in both regulatory affairs and electronic technology solutions. In fact, many of our writers are active and serve in leadership roles in American Medical Writers Association (AMWA) and other life science service organizations. As a result, our regulatory writers are uniquely positioned to apply best practices for content, format, and style to meet global technical requirements.

What We Offer

ISI’s expert regulatory writing team provides the following offerings:

• Strategic regulatory component authoring
  • We author and QC all regulatory components for a variety of submission types (eg, IND, CTA, NDA, BLA, NDS, MAA, DMF, ANDA) with the reviewer in mind, including:
    • Module 2 summaries
    • Module 5 Integrated Summary of Efficacy (ISE)
    • Module 5: Integrated Summary of Safety (ISS)
    • Protocols and protocol amendments
    • Phase 1 through Phase 4 clinical study reports
    • Informed consent forms
    • Investigator brochures
    • Safety narratives
    • Nonclinical study reports
    • IND and NDA/BLA annual reports
• Quality reviews
  • Medical and/or regulatory quality review
  • Verification of consistent messaging across dossier components
  • Assurance of conformance with regulatory standards and expectations
  • Guidance for document content, format, style, and organizational layout
• Regulatory writing management
  • ISI’s regulatory writers have project management and managerial training and experience
  • Organize and lead other functional groups (eg., data management, biostatistics, and publishing) to ensure project success and adherence to timelines
  • Establish timelines and accountabilities and generate a process flow against timelines
• Templates and style guides
  • Guidance and development of company-specific document templates and style guides
• Scientific component authoring
  • Publications for scientific journals
  • Slide decks for scientific conferences and corporate presentations