Regulatory Support

Fractional regulatory support for IND/CTA strategy, submissions, meeting prep, and global planning. V2 specializes in oncology, rare disease, xRNA, ASO, and emerging modality filings.

Our team prepares briefing packages, oversees IND modules, manages Health Authority interactions, and guides sponsors through initial strategy through post-submission commitments. We emphasize clarity, scientific accuracy, and early alignment with regulatory expectations.