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.