From Startups to Cleanups — We Design, Validate, Scale, and Fix 503A, 503B & GMP Operations
THE RESULTS?
Launch Months Sooner
Pass Inspections on the First Try
Outperform Your Competitors
The personalized medicine industry requires more than a one-size-fits-all consulting option.
While others struggle to navigate the highly regulated compounding and evolving GMP industries, our clients thrive. This is because at Restore, our focus is personalized medicine business and compliance advisement for 503A, 503B, cell & gene, and high value drug manufacturing. From guiding start-ups to scaling operationally to facilitating quality & regulatory excellence, Restore helps 503A compounding pharmacies, physician clinics, hospitals, 503B outsourcing facilities, cell & gene labs, CDMOs and beyond to build, grow, and restore their compounding or advanced therapy GMP business.
Why Choose Restore?
Deeply Specialized: Our team includes experts in 503A, 503B, cell & gene, and high-value GMP environments.
Custom Plans, Not Templates — Every engagement is tailored to your facility, processes, and vision.
Demonstrated Outcomes — Clients avoid inspection findings, streamline operations, and complete smooth M&A.
Proactively Prepared — We anticipate shifts in regulation so you're never caught off-guard.
Results in Action
NO 483 FOR 503B
“Restore Health Consulting set us up for success before our first 503B FDA audit. Their regulatory expertise and proactive solutions saved us from receiving a single 483 at opening!”
– Director of Quality, 503B Facility
EFFICIENT CLEANROOM BUILD-OUT
“RHC’s consultants are experts in facility flow for assisting in the cleanroom design phase. They balanced contamination control strategies and operational efficiencies into the layout. The result was a smaller cleanroom footprint and a higher than anticipated throughput.”
-VP of Operations, 503A Pharmacy
HOSPITAL COMPLIANCE MAINTAINED
“As a hospital pharmacy, maintaining compliance is critical for us. For the last 3 years, we’ve used Restore to help us design and implement robust quality systems. The result continues to be no inspection findings.”
-Director of Pharmacy, Inpatient Hospital
BRINGING EQUIPMENT VALIDATION TO 503A
“Even though 503As don’t have to meet rigorous GMP requirements, leadership thought it necessary to bring in some of these concepts where possible. Restore’s validation team came in and validated several equipment and gave us confidence in relying on the performance of the units.”
-PIC, 503A Pharmacy
EASIEST M&A EVER
“Our firm was looking to acquire a pharmacy. Restore found a pocket listing through their network and helped perform due diligence activities. They saved us an immense amount of time and gave us confidence in closing the deal.”
-CEO, Telehealth Firm
ONSITE QUALITY SUPPORT POST M&A
“After acquiring a 503B, we needed to step up the production outputs, which put stress on the quality unit. We sent two of Restore’s quality individuals to be on-site to support the QMS during the transition. Their expertise saved us so much time and money.”
-Head of Quality, 503B
Ready to launch, grow, or restore your facility?
