Regulatory SERVICES

Medical Writing

CSSi LifeSciences combines our unparalleled medical and regulatory knowledge with skilled medical writing to prepare documents that are accurate, clear, concise, and resonate with the appropriate audience. Whether you are targeting a specific regulatory authority, investors, payors, lawmakers, or industry leaders, our biomedical communications professionals have the experience, skills, and expertise needed to craft a compelling narrative.

We provide guidance and expertise ranging from technical writing, editing, and review services to eCTD publishing and filings for Special Designations.

Our communications services also include, but are not limited to:

    • Clinical study protocols, clinical study reports, and supporting study documents
    • Manuscripts and abstracts
    • Regulatory gap reports
    • Investigational New Drug (IND) applications (and addenda/amendments)
    • Clinical Trial Authorizations (CTA)
    • Orphan Drug Designation (ODD) requests
    • Summary analytic and technical documents
    • Regulatory submissions for drug, devices, and animal health
    • Non-clinical PK/ PD summary reports
    • Safety toxicology summary reports
    • CMC validation protocols and reports
    • Human factor studies and reports
    • Responses to the FDA and other health authorities
    • Press releases
    • Corporate and investor presentations

    Learn more about what sets us apart