Core Engagements

Investment: $999 – $1,500

Systematic review of existing documentation against target regulatory framework. Delivers a written gap report with compliance matrix and prioritized action plan — critical, major, and minor findings.
— Documentation audit
— Compliance matrix against target agency framework
— Risk-ranked remediation priorities
— Executive summary for leadership or investors
— One revision cycle included

Investment: $1,500 – $2,500

Strategic pathway architecture for programs entering regulatory development. Designed for founders and development teams who need a regulator-aligned roadmap before committing resources.
— Regulatory pathway mapping
— Jurisdiction and classification analysis
— Risk mitigation modeling
— Development and submission timeline structuring
— Post-session advisory follow-up

Investment: $2,500 – $6,000

End-to-end development of submission-ready documentation built to authority expectations across IND, NDA, ANDA, CTA, or device technical file requirements.
— Structured gap analysis
— Core module drafting (Modules 2–5)
— eCTD structure and formatting alignment
— Submission readiness review
— Two formal review cycles

Investment: $599 – $999

Regulatory defensibility review of product labeling across FDA, EU MDR, Health Canada, and GCC frameworks.
— Label content evaluation
— Claims substantiation analysis
— Classification and compliance assessment
— Structured corrective guidance

Investment: from $750/month

• Essential: $750/month, 2 × 45-min advisory calls + async Q&A (48hr response)

• Strategic: $1,500/month, 4 × 60-min calls + document review + priority response

• Embedded: $2,800/month, Ongoing advisory + up to 10hrs deliverable work included