About GXP Consulting Services
Built by Industry Veterans, for the Companies That Need It Most
We founded GXP Consulting Services because we saw a gap: emerging biotech companies with breakthrough science but without the quality infrastructure to get it to patients. We exist to close that gap.
20+
Years average team experience
150+
Engagements completed
40+
IND and NDA submissions supported
0
Client inspection failures
Our Story
Our Story
GXP Consulting Services was founded by a team of pharmaceutical and biotech professionals who spent decades inside large pharma — at companies like Pfizer, Genentech, and Amgen — before turning their attention to the companies that needed them most.
Early-stage biotech is where the most important science happens. But it's also where quality and regulatory expertise is hardest to access. Large consulting firms are expensive and slow. Hiring full-time QA leadership is premature for most Series A and B companies. The result: critical compliance gaps that delay programs, invite regulatory scrutiny, and cost far more to fix than to prevent.
We built GXP Consulting Services to be something different — a firm that brings enterprise-grade expertise with the speed, flexibility, and cost structure that emerging companies actually need. We embed with your team, learn your science, and build quality systems that are right-sized for where you are today and designed to scale with you.
Deep Expertise
Where We Work Best
Small Molecule Drug Development
GMP manufacturing, analytical method validation, and CMC submissions across all development phases.
Biologics & Biosimilars
Biologics license applications, comparability studies, and GMP compliance for cell culture and purification processes.
Cell & Gene Therapy
Emerging regulatory frameworks, specialized GMP requirements, and quality systems for advanced therapy medicinal products.
Clinical Operations
GCP compliance, clinical quality agreements, and audit programs for clinical-stage companies and their CRO partners.
Regulatory Affairs
FDA and EMA interactions, submission strategy, and technical writing across IND, NDA, BLA, and MAA pathways.
Quality Systems
QMS design, eQMS implementation, and quality culture development for organizations at every stage of growth.
The Team
Leadership
Dr. Sarah Chen
Founder & Principal Consultant
Sarah brings 22 years of pharmaceutical quality and regulatory experience, including senior roles at Genentech and Pfizer. She has led quality operations for three successful BLA submissions and managed FDA pre-approval inspections across multiple manufacturing sites. She founded GXP Consulting Services to bring that expertise to the companies that need it most.
Ph.D. Biochemistry, MIT · Former VP Quality, Genentech · ASQ Certified Quality Auditor
James Okafor
Director, Regulatory Affairs
James spent 15 years at the FDA's Center for Drug Evaluation and Research before joining the private sector. His regulatory intelligence and agency relationships have helped clients navigate complex submission pathways and resolve critical regulatory holds with speed and precision.
J.D., Georgetown University Law Center · Former FDA CDER Reviewer · RAC (US) Certified
Maria Vasquez
Director, Quality Systems
Maria is a quality systems architect with deep expertise in eQMS implementation, process validation, and GMP compliance for both small molecule and biologic manufacturing. She has designed and deployed quality management systems for over 30 biotech clients across the US and Europe.
M.S. Pharmaceutical Sciences, UCSF · Six Sigma Black Belt · ASQ CQE
How We Work
Our Principles
Embedded Partnership
We work alongside your team — not above it. We learn your science, your culture, and your constraints before we recommend anything.
Right-Sized Solutions
We don't apply enterprise frameworks to Series A companies. Every engagement is scoped to your stage, your resources, and your timeline.
Regulatory Integrity
We never cut corners. Our reputation — and your program — depends on quality systems that hold up under the most rigorous scrutiny.
Practical Expertise
We've sat in the seats your team sits in. Our advice is grounded in real-world experience, not textbook theory.
Let's talk about your program.
Whether you're building your first quality system or preparing for a pivotal inspection, we'd like to understand your situation and see if we're the right fit.
No retainer required. Start with a discovery call.
Schedule a Discovery Call