Pre-IND, IND, and NDA Consulting Services

Investigational New Drug (IND) Submission Services

Move from Strategy to Clinical Execution

An IND submission must demonstrate scientific rigor, operational readiness, and a coherent regulatory narrative. FDA’s 30-day safety review leaves little room for ambiguity.

Our team of regulatory experts approach IND submissions with a proactive mindset, starting with the end in mind. We anticipate potential FDA concerns and address them before they become delays.

ProPharma's IND submission support includes:

• End-to-end IND regulatory strategy development
• Module-level content development and review
• CMC regulatory oversight and readiness assessment
• Nonclinical and clinical strategy alignment
• eCTD publishing and technical validation
• Cross-functional submission management
• FDA information request and clinical hold response support

New Drug Application (NDA) Strategy & Submissions

From Data to Approval Strategy. Your Partner at Every Step.

NDA success depends on more than compiling data. It is the culmination of your development strategy and the foundation of your product’s commercial future. It requires a cohesive regulatory narrative that supports benefit-risk, labeling strategy, and long-term lifecycle planning.

Our team of NDA submission experts focus on clarity, defensibility, and alignment. With more than 40 years' experience preparing and submitting applications to FDA, we ensure your submission tells a compelling story founded in scientifically rigorous data.

• Develop comprehensive NDA filing strategy
• Prepare for and lead Pre-NDA meetings
• Craft integrated summaries (ISS/ISE) with regulatory clarity
• Align clinical, statistical, and safety narratives
• Develop labeling strategy and negotiation positioning
• Manage Module 2–5 authoring and review
• Provide full eCTD publishing and lifecycle management
• Support Advisory Committee preparation
• Lead FDA deficiency and information request responses