Marketing Approval Applications
Medpace Medical Writers have produced more New Drug Applications (NDAs) submissions resulting in FDA approvals in the past decade than most of our competition. Our medical writing staff has extensive experience in preparing the clinical components of Marketing Approval Applications in CTD format, including:
- Clinical study reports (Phase I-IV).
- Clinical Summaries.
- Biopharmaceutical and Clinical Pharmacology Sections.
- Integrated Summaries of Efficacy and Safety.
- Clinical Overviews.
- Labels.