Our Story

Restore Health Consulting was built in response to one of the most significant regulatory shifts in modern compounding history.

Following the 2012 New England Compounding Center meningitis outbreak, the industry underwent a fundamental transformation. The passage of the Drug Quality and Security Act in 2013 introduced the 503B outsourcing facility designation, reshaping how compounded medications are produced, regulated, and distributed.

At the same time, state Boards of Pharmacy began increasing oversight, inspection frequency, and enforcement expectations across 503A compounding operations. Many pharmacies were forced to make a decision: invest heavily to meet a new regulatory standard or exit the market entirely.

Restore Health Consulting was established within this environment, not as a theoretical advisory firm, but as a practical partner to organizations navigating real regulatory, operational, and financial pressure.

Over the years, we have supported a broad range of projects across 503As, 503Bs, telehealth platforms, med spas, cell & gene labs, analytical testing labs, and drug wholesale facilities. Today, we are actively engaged in approximately 30–40 concurrent projects each month, supported by a network of 20–30 experienced consultants, helping organizations execute startups, expansions, remediation efforts, and operational scale.

Our work spans regulatory strategy, facility and process design, quality systems, commissioning/qualification/validation (CQV), and business operations.

It is grounded in firsthand operational experience and a practical understanding of what it takes to design, build, and sustain inspection-ready operations in highly regulated environments.

This positions us at the intersection of regulatory strategy, operational execution, and technical design, supporting organizations, operators, and investors in building scalable, compliant platforms for long-term growth.