Investigational New Drug (IND)

Medpace Medical Writers have deep insight into the specific areas of drug approval and understand the appropriate methodologies for Investigational New Drug (IND) submissions. Our experts know what FDA reviewers are looking for and deliver superior medical writing, data analysis, and research skills to your project.

• Our IND associated goals and responsibilities typically include:
• Pre-IND and Pre-NDA meetings (briefing book preparation, meeting support and attendance, and regulatory strategy guidance).
• IND submission and IND maintenance (submission and tracking of IND Safety Reports, Annual Reports, and Amendments).