RAQA Regulatory Firm

We are a global consulting firm specializing in FDA and ISO regulatory compliance for the medical device, pharmaceutical, and manufacturing industries. With decades of hands-on experience in quality systems and process validation, end-to-end support in sterilization validation (EtO and radiation), cleaning and equipment validation, CAPA remediation, design controls, gap analysis, and inspection readiness. Our team includes former FDA investigators and lead auditors who understand both regulatory expectations and practical implementation. We guide clients through 21 CFR Parts 820, 210, 211, 4, and ISO 13485 compliance, offering tailored solutions to ensure audit success and sustainable quality systems. Whether preparing for an FDA inspection, validating a sterilization process, or maintaining global compliance programs, we deliver reliable, science-based, and cost-effective consulting trusted by manufacturers worldwide.