HOW DDC-C can ensure success
Regulatory Strategy Development
Regulatory Strategy Development
Regulatory Strategy Development
Develop and optimize US/global regulatory strategy (IND/CTA/Orphan/Expedited Pathways)
Identify development gaps and design mitigation plans
Map regulatory risks and agency expectations by modality or indication
IND-Readiness and Authoring
Regulatory Strategy Development
Regulatory Strategy Development
Author or QC Module 2 summaries and Module 1 documents
Coordinate with CMC and nonclinical leads to ensure alignment
Drive timelines to submission — from planning to eCTD handoff
Regulatory Agency Meeting Support
Regulatory Agency Meeting Support
Regulatory Agency Meeting Support
Prepare briefing packages and key messaging
Coordinate pre-IND or scientific advice meetings (FDA/EMA)
Provide mock Q&A sessions and meeting rehearsal coaching
Regulatory Operations Oversight
Regulatory Agency Meeting Support
Regulatory Agency Meeting Support
Source and manage publishing vendors if needed
Ensure documents meet formatting and regulatory requirements
Track commitments and correspondence post-submission