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Regulatory and Clinical Strategic Planning

Develop regulatory & clinical strategy matched to your technology to accelerate programs to first in human clinical trials. Perform indication prioritization and develop target product profile (TPP) and align clinical and regulatory milestones with funding requirements and investor expectations.

Regulatory Advice and Consulting

Assist with FDA submissions (IND and BLA), and requests for expedited programs designations (Fast Track, BTD, RMAT, Platform Manufacturing) and general meetings (CATT, INTERACT, PreIND, PreBLA, Type A, C and D). Provide advice about manufacturing platform, process and product development and analytics.

Compliance Support

Conduct mock facility inspection, vendor audits, and assist with post approval manufacturing changes (AR, CBE, PAS) and preparation of Type C facility meeting.