Submission Planning and Readiness

Submission preparation requires more than collecting documents. Scientific content must be complete, consistent, and aligned across functions.

I help teams organize submission activities, identify gaps, and prepare documentation that clearly communicates the development program and its supporting evidence.

• IND and CTA preparation and maintenance.
• IMPD and CTD content planning.
• NDA, BLA, and MAA readiness assessments.
• Submission schedules and document responsibility matrices.
• Authoring and scientific review within the agreed scope.
• Cross-document consistency and completeness checks.
• Coordination with writers, technical contributors, and publishing specialists.
• Health authority response preparation.

A submission plan, document tracker, readiness assessment, reviewed content, and an action plan for resolving outstanding issues.