API
FDA Inspections
- Pre-inspection readiness
- War-room handling/support during inspections
- Form 483 and warning letter response support
- Regulatory meeting preparation and support
FDA Pre-Approval Inspections (PAI)
Mock Inspections and cGMP assessments
Investigation and CAPA System
- Laboratory, Manufacturing and Complaint support and backlog reduction
- Retrospective/Prospective review
- Investigations/complaints handling outsourcing
Human Error Reduction and Prevention Programs
Implementation and enhancement of Quality Risk Management programs
Annual Product Review/Product Quality Review Support abnd Outsourcing, including Data Trending and Analysis
Computer System Validation and 21 CFR Part 11
Data Integrity audit and Assessment, Remediation and Training
Validation Life Cycle
- Laboratory Test Methods development and transfer (analytical & microbiological) / LIMS
- Facilities/Utilities/Equipment
- Cleaning
- Processes
- Sterilization methods
Operational support
- QC Laboratory analysts
- QA Documentation and Change Control
- Documentation Simplification and Enhancement
- Batch Record Enhancement
- Sampling Plans Assessments and Statistical support