Regulatory Submissions
Medical Writers Group, LLC produces regulatory documentation (phase 1-4), including clinical study reports (CSRs), clinical protocols, investigator brochures, narratives, PSURs, ISS/ISEs, INDs/NDAs, & eCTDs. MWG can assist with study design, adverse event analysis, and data interpretation.MWG prepares all regulatory submissions in accordance with FDA, ICH, GCP, and CIOMS I-VII standards and guidelines.
