Services, Pricing, and Timelines

FDA & Regulatory Readiness: 2-Week Sprint

Best for Pre-IND, Q-Sub/Pre-Sub, or Teams Preparing for High-Stakes FDA Review

Clear, defensible regulatory positioning, before FDA questions cause delays

$5000 (2 weeks)

Identify regulatory gaps and hidden risks
Align testing strategies with FDA expectations
Prepare your team for meetings, questions, and submissions

Sterility & Microbial Risk Assessment

Best for: Cell & Gene Therapy Manufacturers, LBPs, Biologics, and Other Advanced Manufacturing

Reduced risk of sterility failures and regulatory pushback

$4000 (2-3 weeks)

Review sterility testing strategy and data
Evaluate rapid (alternative) microbial methods for regulatory defensibility
Provide a written risk and mitigation plan

Investor & Partner Due Diligence Support

Best for: Fundraising, Partnerships, Acquisitions

Confidence for investors, partners, and boards

$3000 (1 week)

Independent expert review of manufacturing QC and sterility claims
Identify technical and regulatory red flags early
Provide a concise diligence memo for decision‑makers

Most engagements start with a 90-minute paid advisory call ($500), which is credited toward the cost of any subsequent engagement.

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