Regulatory & Quality Compliance

Jul 11, 2025

Regulatory & Quality Compliance

Quality and safety are at the core of everything we do. Our operations are GMP-compliant, built on rigorous protocols that meet international standards. At the core is a HACCP-based approach, supported by Prerequisite Programs (PRPs) such as hygiene control, zoning, sanitization programs, pest control, and an environmental monitoring program. These foundational systems minimize contamination risks and support safe, consistent operations.

We further implement Operational Prerequisite Programs (OPRPs) – targeted control measures critical for mitigating key food safety hazards – integrated directly into our validated processes and standard operating procedures (SOPs). In addition, we adhere to Good Documentation Practices (GDP) to ensure that all records, logs, and reports are complete, accurate, and traceable. This strengthens compliance, facilitates audits, and ensures transparency across every production batch.

With ScaleUp Bio, you can trust that your products are developed and manufactured to the highest standards, ensuring consumer safety and market acceptance.


Certifications

  • FDA-registered (current)
  • SFA-licensed (current)
  • HACCP certification (2025)
  • FSC 22000 (2026)