Medical Writing

Our team of experienced industry medical writing professionals uses their medical science expertise and writing skills to precisely review and summarize complex data into document formats that comply with regulatory requirements. We are equipped to provide full spectrum medical and regulatory writing services from pre-clinical reports through drug development and post-marketing documentation and labelling. We ensure consistent style and messaging across your program documents, with realistic pre-approved timelines, and efficient reconciliation of stakeholder’s feedback to create superior documents, such as:

Clinical development plans
ICFs
Nonclinical and Clinical protocols
Clinical study reports
Investigator’s Brochures
IND/NDA Dossiers
Annual reports (DSUR/PSUR)
Aggregated safety reports
Educational and training materials
Posters and manuscripts