Restore Health Consulting brings deep regulatory knowledge, operational experience, and strategic clarity to the compounding industry. From audit readiness to facility expansion, expert witness support to feasibility analysis—we’ve helped clients pass inspections, avoid enforcement, optimize facility design, and make confident go/no-go decisions. Below are just a few examples of how our work has made a measurable difference.

Facility Design, Feasibility, & Expansion 

30+ Facilities Designed with Compliance & Throughput in Mind

Over a span of 3 years, we developed vision documents and layout strategies for 30+ clients—maximizing throughput and compliance with the smallest cleanroom footprint.

USP <800> Feasibility for Clinical Trial Compounding Pharmacy

We assessed options to expand into HD sterile compounding, evaluated four buildout paths, and gave the client a strategic roadmap.

Global Pharma Reassesses 503B Entry After Full Due Diligence

We delivered risk research, a sample layout, revenue modeling, and site readiness review. They chose not to pursue—saving millions.

Big Pharma Evaluates 503B Expansion Strategy

We provided gap assessments, SOP reviews, and a roadmap to 503B readiness. The client ultimately pivoted away from the plan, but retained all deliverables for future use.

 Audit Readiness & Regulatory Defense

503A in California Passes Inspection & Closes M&A Deal

We helped a high-risk, sterile nonsterile-to-sterile pharmacy address CA Board gaps before inspection. They passed with no findings and completed a successful acquisition.

503A Secures NABP Accreditation After Deficiencies

We performed a full gap analysis and helped the client submit a successful response. Accreditation was granted without reinspection.

503A Pharmacy BUD Dispute Resolved Without Penalty

A Board inspector challenged their BUD. We found a lab error, got the study redone, and avoided enforcement.

503B Opens With Zero 483s—An Exceptionally Rare Result

Our pre-inspection audit caught critical gaps. The client remediated, and FDA found no observations.

Comprehensive 503A Gap Analyses Across the Country

From hospital Category 1 to high-risk sterile-to-nonsterile Category 3, we help 503As prepare for inspections with a proven four-phase methodology.

 Expert Witness & Legal Support

Expert Testimony in High-Stakes Regulatory Cases

From BUD defense to essential copy and compounding allegations, our insight helped clients win or settle major Board and legal actions.

 Regulatory Strategy & Drug Eligibility

WHO-Recognized Drug? Not Legal to Compound in U.S.

We performed a feasibility study for a global company seeking to compound a lifesaving API. Our research showed no legal pathway—and saved the client from regulatory exposure.

 CGMP Validation Services

CIP Validation for High-Throughput Nonsterile Line

We validated a complex clean-in-place process for a proprietary nonsterile automation system—designing sampling strategies, acceptance limits, and a custom protocol that passed on the first try.

Temperature Mapping: Warehouse & Controlled Units

We temperature-mapped the client’s full warehouse and all refrigerators, freezers, and incubators—resolving excursion risks and passing FDA inspection with zero observations.

IQ/OQ/PQ for Depyrogenation Oven & Autoclave

We qualified new sterilization equipment with full cycle development, BI testing, and audit-ready documentation—ensuring FDA compliance from day one.

Computer System Validation for Electronic QMS

We led a full CSV project for a 503B’s transition to electronic batch records and deviation tracking—ensuring 21 CFR Part 11 compliance and seamless inspection readiness.