FDA NDA Submission Support

Regulatory Operations

The Challenge: Coordinating a Massive Submission

A pharmaceutical client was preparing for their first **New Drug Application (NDA)** submission for a novel analgesic. The submission required coordinating over 500 documents across Module 2 (Summaries), Module 3 (Quality), and Module 5 (Clinical Reports).

Inconsistency in document formatting and style between different CRO partners threatened to cause validation errors during the eCTD compilation process.

Our Solution

MedicoWriter acted as the central medical writing hub:

• Standardization: Developed a unified detailed style guide and document templates for all vendors to use.
• Granular Tracking: Implemented a module-level tracker to monitor drafting, QC, and approval status of every document.
• Quality Review: Conducted cross-document consistency checks (e.g., ensuring AE tables in Module 2.7.4 matched the CSRs in Module 5).

The Result

The FDA accepted the submission for review without any "Refuse-to-File" issues. The consistent quality of the dossier was noted during the review process, contributing to a smooth approval.

"Your attention to detail is unmatched. You caught inconsistencies between Module 2 and 5 that our internal team missed completely."