Our Areas of Expertise
- Oncology (solid and liquid tumors)
- Infectious diseases
- Neurology and CNS
- IgG disorders
- Diabetes
- Women’s health
- Rare and orphan
- Conference brochures
- Abstracts
- Posters
- Slide presentations
- Speaker biographies
- Internal reports
- Executive summaries
- Investigational New Drug (IND) applications
- Clinical study reports (CSRs)
- Patient narratives
- Study protocols and amendments
- Pediatric study plans (PSPs)
- Risk management plans (RMPs)
- Manuscripts
- Investigator’s brochures
- Safety reports (Development Safety Update Report [DSUR] and IND annual reports)
- Meeting information packages for regulatory agency meetings
- New Drug Applications (NDAs)
- Biologics Licensing Applications (BLAs)
- Marketing Authorization Applications (MAAs)
- Common Technical Documents (CTDs)
- Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE) sections
- Safety reports (120-day safety updates and Periodic Safety Update Reports [PSURs])
- Responses to questions (RTQs) from regulatory agencies
- API guides
- Help documentation
- Tutorials