Science, Regulatory, and Medical Writing Services

 

Medical writing is not about following templates and guidelines, but being passionate about effectively communicating a succinct, coherent, and scientifically accurate story. Regulatory documents and scientific publications are complex documents but have to be well-written and have to be reader-friendly to effectively communicate the key messages to regulatory authorities and key target audience.

Experienced in development of a variety of clinical and regulatory documents in support of Phase 1-4 clinical trials

  • Clinical study protocols and amendments

  • Clinical study reports (CSRs)

  • Investigator’s brochures (IBs) and annual updates

  • Development safety update reports (DSURs)

  • Patient safety narratives

  • Briefing documents for submission to health authorities

  • Integrated summaries of effectiveness and safety (ISE/ISS)

  • Clinical sections of Investigational New Drug (IND) application, New Drug Application (NDA), and Biologics License Application (BLA)

Experienced in development of a variety of publications

  • Primary research manuscripts, including publication based on investigator-sponsored trials

  • Comprehensive review articles

  • Meeting abstracts

  • Slide decks

  • Posters

  • Competitive intelligence reports

Therapeutic disciplines

Successfully developed content supporting a broad range of therapeutic disciplines, including neurology, ophthalmology, nephrology, oncology, dermatology, and rheumatology

Standards and Guidelines

All documents are prepared per applicable standards and guidelines, including FDA, EMA, ICH, GCP, corporate SOPs, AMA Manual of Style, and journal guidelines