Manage constantly evolving regulatory protocols and submission guidelines with our medical writing experts.
The Big Picture
From protocol development and informed consent to regulatory support and publishing, we deliver accurate, clearly written documents prepared by experienced medical writers.
All documents go through rigorous scientific, statistical, editorial, and quality control review, always compliant with FDA, EMA, and other regulatory requirements.
Veranex medical writing has generated over 500 CSRs, protocols, IBs, ICFs, and safety narratives with experience in early to late phase studies and submissions for drugs and devices.
Medical Writing Services and Capabilities:
- Initial document development of protocols, investigator brochures (IBs), informed consent forms (ICFs) to
- Periodic regulatory reporting needs for development safety update report (DSUR) or periodic safety update report (PSUR), to
- Submission documents such as clinical study reports (CSRs), safety narratives, and CTD Module 2 summaries for clinical and non-clinical sections of a submission
- Submission publishing/eCTD document publishing for an electronic submission gateway dispatch
- Report publishing using publishing tools and Documentum
- Redaction services for data protection
- Clinical trial registration and results posting on clinicaltrials.gov
- Publication abstracts, manuscripts, and conference posters
- Extensive experience in PK and clinical endpoint/bioequivalence studies