“Your Trusted cGMP & FDA Consulting Partner in Biotech Scale-Up”
“Driving Biotech Growth with Proven cGMP and Regulatory Expertise”
“Expert Guidance from Discovery to FDA Approval — Powered by cGMP Precision”
“cGMP Experts Guiding Biotech from Lab Bench to Market Success”
At Woodbrook Consulting Partners, we specialize in guiding biotech and life sciences organizations through complex cGMP implementation, regulatory navigation, and FDA approval readiness. Our proven approach integrates scientific rigor with operational execution — helping innovators move confidently from discovery through scale-up, launch, and sustained success.
We Have You Covered
🔬 cGMP Compliance & Quality Systems
Facility and process readiness assessments
QMS development, audit prep, and remediation
CDMO/CRO oversight and vendor qualification
📋 Regulatory Strategy & FDA Submission Support
IND, NDA, and BLA planning and filing support
CMC documentation and data readiness
Regulatory gap assessments and agency interaction prep
🚀 Commercialization & Scale-Up
Supply chain design and operational scale-up
Tech transfer planning and execution
Cold chain logistics, batch optimization, and launch readiness
📈 Strategic Operations & Program Execution
End-to-end project management for clinical and commercial programs
SIOP/IBP implementation and planning analytics
Risk mitigation and scenario modeling for growth
Your Trusted Partner
We are a biotech and life sciences consulting firm specializing in cGMP compliance, regulatory strategy, and commercialization. From early discovery to FDA approval and global launch, Woodbrook provides expert guidance across every stage of the product lifecycle.
Our strength lies in translating complex scientific and operational challenges into actionable strategies that accelerate success — whether you're preparing for an IND, scaling manufacturing, or entering new markets.
We’re cGMP experts, trusted by innovators to deliver the clarity, speed, and compliance needed to thrive in today’s regulated environment. should make a purchase. Tap into your creativity. You’ve got this.
What Our Clients Say
"Woodbrook brought structure and foresight to a complex cold chain network. Their input on scale-up and SIOP planning directly improved our patient service levels."
— Global Supply Chain Lead, Radiopharmaceutical
Keith Finley
"We bring Woodbrook in post-Series A to stabilize operations and de-risk execution. They’ve become a critical partner across our biotech portfolio."
— Partner, Life Sciences VC
Monet Goode
"Woodbrook helped us move from preclinical chaos to IND readiness in record time. Their cGMP knowledge and regulatory insight saved us months of rework — a game-changer for a company our size."
— CEO, Early-Stage Oncology Biotech
Channing Lee
