Solutions That Save Compounders Time and Money
We Advance the Business and Compliance Status of 503A Pharmacies & 503B Outsourcing Facilities Through Our Comprehensive Consulting Programs.
The personalized medicine industry requires more than a one-size-fits-all consulting option.
While others struggle to stay ahead in the highly regulated compounding industry, our clients are thriving. This is because at Restore, our sole focus is 503A & 503B business and compliance advisement. From conducting current market assessments and guiding pharmacy start-ups to strategizing revenue growth and facilitating regulatory excellence, Restore helps 503A compounding pharmacies, home infusion pharmacies, physician clinics, hospitals, 503B outsourcing facilities, and CDMOs build, grow, and restore their compounding business.
BUILD
Comprehensive consulting for compounding start-ups
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To BUILD a successful 503A or 503B business.
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Compounding start-ups - 503A compounding pharmacy, infusion pharmacy, hospital pharmacy, physician compounding service, and 503B outsourcing facility.
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The services below bring new compounding firms to market in three-phases (a la carte services also available).
GROW
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.
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Make informed pre-investment decisions and close mergers & acquisitions deals.
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Established firms - 503As, 503Bs, private equity, and venture capital.
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1. Market assessment
2. Facility gap analysis
3. Due diligence
4. Strategic planning
5. Implementation summary
6. Proforma modeling
RESTORE
Investigative & corrective consulting
Root Cause
Gap Analysis
CAPA
Regulatory Response
Summary Report
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To RESTORE compound quality, regulatory compliance, or operational excellence.
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Solution-focused 503As & 503Bs that want to stay ahead of regulations or respond to quality or compliance insufficiencies.
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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.
It all Begins with a Conversation
Whether you are starting / growing a 503A compounding pharmacy or 503B outsourcing facility, or need to quickly respond to an FDA 483, warning letter, or Board of Pharmacy observation, our compounding consultants can help.
We know that finding the right consultant is a choice not to be taken lightly. That’s why we offer free consultations to walk you through your needs, the scope of your goals, and your budget.
Our Courses
Looking for ACPE accredited sterile compounding CEs? Take one of our courses!
