We help conduct business risk assessments and implement suitable operational process improvements for maintaining compliance with all applicable regulations (US and International).From small initiatives to large-scale operational transformations, we are here to help you navigate every challenge with confidence.

Experience & Skills

Risk-based approach for process implementations

Regulatory Compliance (QSR, ISO, HIPAA, SOC2, NIST, GDPR)

Use of Six Sigma methodologies to increase operational efficiency

IRB, Clinical Studies review/approval/submissions

Contract Assembly Solutions (From prototyping to mechanical assembly, kitting, packaging, labeling, and inspection).

US-based operations and support

Founder/Owner

Walter cORDIGLIA,SSMBB,CHP

Solutions-oriented and Six Sigma Master Black Belt executive with 20 years of extensive experience in process improvements, operations, quality engineering, manufacturing, clinical compliance, and regulatory affairs.

Let’s get started

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