We empower 503A pharmacies, 503B outsourcing facilities, cell and gene therapy innovators, and high-value GMP drug manufacturers.
Whether you're launching a new venture, expanding, or navigating compliance challenges, our programs drive operational excellence, regulatory compliance, and business growth.
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 personalized medicine 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.
Comprehensive consulting for compounding & personalized medicine start-ups
To BUILD a successful 503A, 503B, or advanced therapy GMP drug manufacturing facility.
Personalized medicine start-ups - 503A compounding pharmacy, infusion pharmacy, hospital pharmacy, physician compounding service, 503B outsourcing facility, cell & gene lab, high value drug manufacturing, etc.
The services below bring new personalized medicine firms to market in three-phases (a la carte services also available).
Fast-paced strategic consulting
Some GROW clients may also opt or require other services such as fractional leadership, accreditation, licensing, or product development. All of our services are available a la carte.
Make informed pre-investment decisions and close mergers & acquisitions deals.
Established firms - 503As, 503Bs, GMP, cell & gene, GMP firms, CDMO, private equity, and venture capital.
1. Market assessment
2. Facility gap analysis
3. Due diligence
4. Strategic planning
5. Implementation summary
6. Proforma modeling
Investigative & corrective consulting
Root Cause
Gap Analysis
CAPA
Regulatory Response
Summary Report
To RESTORE compound or other personalized medicine quality, regulatory compliance, or operational excellence.
Solution-focused 503As, 503Bs, cell & gene labs and other personalized therapeutic focused GMP companies that want to stay ahead of regulations or respond to quality or compliance insufficiencies.
RESTORE is investigative & corrective consulting that includes: a root cause investigation or gap analysis audit, CAPA plan, and regulatory response or summary report. Some clients may opt or require additional advisement such as fractional leadership, training, continuing education, SOP customization, facility renovation, accreditation, licensing, probationary monitoring, or expert witness services.
Multidisciplinary Expertise: Our team includes seasoned professionals in GMP manufacturing, advanced therapies, and compounding pharmacy operations.
Tailored Solutions: No two clients are the same. We customize every plan to meet your unique needs and goals.
Proven Success: Trusted by clients across compounding pharmacies, cell and gene therapy, and ATMP manufacturing to deliver measurable results.
Forward-Thinking: We stay ahead of industry trends to ensure your business remains compliant and competitive.
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
In compliance with industry confidentiality requirements, we maintain anonymity for all client testimonials while highlighting the value and outcomes our clients experience.
