Pearl ReGXP

Regulatory and Compliance Acceleration

Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GXP auditing services.

Regulatory Strategy:
Design global regulatory strategies that can trim months and dollars off your product development path.

Regulatory Filings:
Expertly negotiate global health authorities’ interactions and filings.

GXP Quality Systems:
Create efficient and compliant CGMP/GLP/GCP/GPP quality systems.

Training:
Create tailored training programs to ensure compliance needs.

Auditing:
Increase internal and external capacity to ensure compliance with oversight expectations.

Validation Support:
Creating the appropriate validation strategy and executing it throughout the project.

Remediation:
Problems do arise. Our team will assess, develop a plan, work with the FDA as needed, and help clients implement CAPAs.