Biologics Consulting
From IND to First-in-Human — I've Done It
Anderson Biologics Consulting brings 25 years of hands-on experience in translational cell therapy, IND strategy, and GMP quality systems to early-phase biotech programs.
My Services
I bring deep, firsthand expertise to the two most critical pillars of early-phase cell therapy and biologics development.
CMC & GMP Development
IND-Enabling CMC Strategy, GMP Quality Systems & Manufacturing Support
Early-phase CMC and quality infrastructure are often the most underestimated challenges for translational programs. I guide emerging biotech companies through IND-enabling process development, GMP quality system design, cleanroom facility commissioning, and CDMO oversight — building a manufacturing foundation that satisfies FDA for Phase 1 and scales efficiently.
I have personally led GMP facility commissioning, quality program development, and IND-enabling manufacturing for autologous cell therapies, iPSC-derived products, and other early-phase investigational biologics.
Learn more about CMC services→
Regulatory Strategy
IND Strategy, FDA Submissions & Regulatory Affairs
For translational programs, regulatory strategy begins long before your first IND submission. I help biotech founders understand the IND-enabling regulatory landscape, design development programs that align with FDA expectations, and prepare pre-IND meeting requests and IND applications that move efficiently through review.
I have served as Chief Regulatory Officer at a cell therapy startup, with primary responsibility for the strategy, authoring, and submission of a first-in-human IND for autologous cardiac cells derived from iPSCs — and have navigated FDA, FACT, and AABB inspections throughout my career.
Learn more about regulatory services→Why Work With Me
You Work Directly With Me
There are no junior consultants, no account managers, and no handoffs. Every engagement is led by me personally — so you get direct access to 25 years of hands-on experience, on every call and in every deliverable.
Built for Early-Stage Cell Therapy & Biologics
I understand the resource constraints and urgency of translational programs. My approach is practical, milestone-focused, and designed to maximize the impact of every dollar you invest in IND-enabling development.
Regulatory and Quality in One Practice
IND strategy and GMP quality systems are inseparable in early-phase manufacturing. I bring both lenses to every engagement — ensuring your manufacturing infrastructure and your regulatory submissions are built to work together from day one.
Ready to Accelerate Your Program?
Whether you're preparing your first pre-IND meeting, building out your GMP quality system, or navigating a complex IND submission, I'm here to help. Let's talk about your program.