Assess, improve and maintain compliance while advancing operational efficiency.
Ensuring compliance and demonstrating control throughout the product lifecycle is essential for brand reputation and meeting global health authority requirements. Verista’s consultants possess a large breadth and depth of expertise and industry experience assessing and implementing compliance systems and ensuring regulatory compliance. We help define and guide clients on the optimal pathways of their approval process and ensure that all requirements are completed successfully and efficiently while directly interacting with agencies. We have the expertise to tailor support specific to your needs.
Regulatory due diligence activities.
FDA submissions support.
Regulatory agency meetings support.
Pre-approval inspection readiness support.
Auditing, Inspection Readiness & Remediation
Construction and implementation of vendor auditing programs, inspection readiness walkthrough programs and internal auditing programs.
Mock audit performance and Inspection hosting and backroom management.
Post-inspection remediation planning, issue resolution, remediation activities, regulatory response support and inspection report management.
Form 483 and warning letter remediation, and regulatory response support.
Execution and reporting of external vendor audits.
Quality & Compliance
QMS development and remediation support.
Performance of gap analysis and data integrity & privacy assessments.
Risk assessment performance and program development.
Quality as a Service (QAAS), in-house quality assurance and sterility assurance support.
Product Lifecycle Management
CMC Management and analytical method development, validation and verification.