Protocol Design

Custom Protocols That Meet the Standards—and Match the Science
503A pharmacies & hospitals, 503B outsourcing facilities, and GMP life science manufacturers—including cell & gene therapy programs—must meet rigorous regulatory and accreditation expectations specific to their industry and site. Off-the-shelf master formulas and generic validation templates aren’t enough.

Restore Health Consulting develops customized protocols that reflect your specific processes, facility design, equipment, and regulatory requirements.

 

What We Do

We help ensure your protocols support quality production, compliance and accreditation requirements pertinent to your industry (e.g., FDA 21 CFR Part 210/211 or FDA section 503A of FDCA, DEA, USP <797>/<795>/<800>, state Boards of Pharmacy, NABP, PCAB, etc.)

For Pharmacies

  • Standardized master formula templates

  • Media fill protocols

  • Sterile and non-sterile process validations

For GMP Facilities

  • Aseptic Process Validation

  • Cleaning & SIP/CIP Validation

  • Environmental Baseline Studies (EMPQ)

  • Assay & Analytical Method Validation

  • Process Transfer and Shipping Validation

  • And More!