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.
Design global regulatory strategies that can trim months and dollars off your product development path.
Expertly negotiate global health authorities’ interactions and filings.
GXP Quality Systems:
Create efficient and compliant CGMP/GLP/GCP/GPP quality systems.
Create tailored training programs to ensure compliance needs.
Increase internal and external capacity to ensure compliance with oversight expectations.
Creating the appropriate validation strategy and executing it throughout the project.
Problems do arise. Our team will assess, develop a plan, work with the FDA as needed, and help clients implement CAPAs.