A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Medical Writing

InClin’s Medical Writing core team has over 80 years of combined medical writing experience. Our team offers solutions, ranging from single documents to a complete marketing application, tailored to your specific needs.

Our skilled writers become an integral part of your team, guiding the writing, editing, and reviewing processes needed for timely document and project completion. In addition, our writers provide strategic consulting and all other medical writing support.

THE INCLIN ADVANTAGE ENCOMPASSES:

    • Scientific/Medical Expertise — Trained scientists skilled at analyzing, synthesizing, and presenting data, allowing the client to focus on strategic review
    • Comprehensive Experience — Our broad industry knowledge and exposure allows us to tailor our services to achieve your goals and to reach your target audience
    • Customized Solutions — We work with a wide range of companies, from virtual to global corporations, who have diverse products and development needs
    • Proven Quality Processes — We use validated templates and quality reviews to produce high-quality documents that adhere to regulatory style guidelines
    • Collaborative Environment — We work as an integral part of your team with the belief that we can achieve more together
    • Resource Rich — We are flexible and can add writers to your team, as needed, to ensure that timelines are met, even as your project evolves
    • NDA/BLA Medical Writing Expertise — Over 10 NDAs including 505(b)1 and 505(b)2/BLAs/ ANDAs written in the last 3 years by our medical writers

The InClin Advantage Will Set Your Program up for Success

REGULATORY WRITING

      • Investigational New Drug Applications (INDs)
      • New Drug Applications (NDAs)/Biologic Licensing Applications (BLAs)
        • 505(b)1 and 505(b)2 NDAs
        • Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
      • Annual safety reports, including Development Safety Update Reports (DSURs)
      • Briefing books
      • Regulatory responses
      • Prescribing information
      • Orphan drug requests
      • Fast track designation requests
      • Qualified infectious disease product requests (QIDP)

CLINICAL WRITING

      • Protocols (Phase 1 to 4)
      • Clinical Study Reports (Phase 1 to 4)
      • Investigator Brochures
      • Patient narratives

SCIENTIFIC WRITING

      • Abstracts
      • Posters
      • Manuscripts
      • Literature-based research
      • White papers

INCLIN CLIENT TESTIMONIALS

Experience You Can Count On
Clinical and Regulatory Documents Done Right the First Time