Industries We Support
Medical Devices
Clinical Research
Clinical Research
FDA compliance, QMSR, and end-to-end quality systems
Clinical Research
Clinical Research
Clinical Research
GCP, ICH E6(R3), and clinical quality frameworks
Food & Beverage
Clinical Research
Food & Beverage
HACCP, quality systems, and regulatory risk management
Technical Due Diligence
Quality Systems & Compliance
Quality Systems & Compliance
Assess regulatory, quality, and operational risks across FDA-regulated businesses for investors and operators
Quality Systems & Compliance
Quality Systems & Compliance
Quality Systems & Compliance
Design and remediate quality management systems aligned with FDA, QMSR, and global regulatory requirements
Risk Management
Quality Systems & Compliance
Inspection Readiness
Develop and implement risk management frameworks aligned with ISO 14971, FDA, and global regulatory expectations
Inspection Readiness
Quality Systems & Compliance
Inspection Readiness
Prepare organizations for regulatory inspections through gap assessments, remediation, and audit readiness
Why Choose PC Consulting International
Work directly with senior expertise—no layered consulting teams
Extensive experience across FDA-regulated industries
Proven experience supporting due diligence and integration
Focused on implementation—not just recommendations
“The founder of PC Consulting International supported us in quality and regulatory due diligence on a SaaS transaction in the food and beverage sector, a highly regulated FDA environment. We were impressed by their depth of expertise in FDA quality systems and the practical insights they provided."
—Private Equity Operating Partner
"PC Consulting International, led by its founder provided critical support during the quality system integration of an acquired medical device business into a global healthcare organization. Their expertise in FDA quality systems, risk mgt., and audit readiness helped ensure a smooth integration."
— Multi-Site Compliance Director, Medical Device Company