GMP consulting for 503B outsourcing facilities
From site build-out to trained operators.
We work with founders standing up their first sterile compounding facility and with established manufacturers expanding capacity or correcting course after an inspection. The work covers regulatory strategy, product selection, site design and GMP build-out, quality systems, and the SOPs and operator training your facility runs on once the doors open. The expensive mistakes happen early. We help you make those calls, then stay involved while they get executed.
New facilities and established ones
New facilities
Founders building a 503B from scratch, from site selection through first inspection.
Existing facilities
Operators adding capacity, adding products, or fixing findings from an FDA inspection.
The full path from plan to running facility
Startup strategy
Market entry planning for new 503B facilities.
Regulatory navigation
FDA strategy and inspection readiness, with input from former FDA investigators.
Product selection
Deciding which products to make, and in what order.
Site design and build-out
GMP facility design and commissioning support.
Quality systems and SOPs
Systems and procedures built to scale with you.
Operator training
Onboarding, training and qualification programs.
We work directly with former FDA investigators
Our recommendations are shaped by people who have inspected facilities for the agency. For inspection readiness, Form 483 responses and quality system reviews, that means advice grounded in how FDA actually evaluates a 503B, not guesswork.
Funk Consulting Group is an independent firm and is not affiliated with or endorsed by the U.S. Food and Drug Administration.
Three steps, no commitment up front
Intro call
A free 30-minute call to understand where you are.
Readiness review
Optional: a 60-minute review plus a written readiness report.
Proposal
A scoped proposal for the work, if it makes sense.
An expert look at your facility, in writing
A fixed-price review for founders and operators who want a clear, independent read on where they stand. Share your plans or documents, we work through your top questions together, and you leave with a written report you can act on.
- Review of your plans, documents or facility details before we meet
- 60-minute working session on your top questions
- Written readiness report within 3 business days
- Prioritized findings and a recommended next-steps plan
James Funk
I run a consulting practice for 503B outsourcing facilities and I am finishing a PhD at Purdue studying peptide drug delivery.
Before starting the practice, I was the founding employee at ProRx, a 503B outsourcing facility, where I helped bring sterile manufacturing online, build out the facility and bring in new clients.
As a BioTrain Fellow, I teach biopharmaceutical manufacturing through lectures and hands-on labs for undergraduates, graduate students and industry professionals.
More about JamesStarting a 503B or fixing one? Let's talk.
Available 24/7. Production problems don't keep business hours, and neither do I. Clients can reach me at any hour, day or night, seven days a week, at (484) 798-5271.
Book a free 30-minute call