Blue Oaks Biotech helps life science companies confidently navigate the path to GMP, IVD, and commercial readiness. Founded by Teresa Henry, Ph.D., in San Diego, California, our team combines deep scientific understanding with hands-on operational expertise. We partner with small and emerging biotech organizations to translate discovery into manufacturable, compliant, and scalable solutions.
We evaluate development stages and GMP/IVD readiness, creating tailored, risk-based roadmaps that align with your goals.
Expert oversight across drug development, analytical, regulatory, and quality functions ensures data integrity and cross-functional alignment.
From CDMO selection to tech transfer execution, we manage partnerships that sustain quality and operational efficiency.
We design and implement QMS frameworks that build confidence with regulators and enable smooth scale-up.
Our team supports regulatory submissions, authoring technical documentation like batch records, procedures, specifications, and regulatory sections such as IND/BLA Module 3.

At Blue Oaks Biotech, our values guide every interaction. We believe in science-based decisions grounded in data and guided by what works. Our people-first partnerships are rooted in trust, clarity, and collaboration. We champion strengths-based resourcing, ensuring that each team member contributes their best expertise. Most importantly, we view challenge as opportunity and approach every obstacle as a chance to learn, grow, and strengthen our industry.
We support innovators across the life sciences: Pharmaceuticals & Biotechnology, Diagnostics, Cell & Gene Therapy, and Cell-Cultured Products. Our adaptable model and experience across regulated industries allow us to meet clients where they are and grow with them through each milestone.
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