COMBINATION PRODUCTS
Implementation of FDA cGMP/Compliant Quality System
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/QSR 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 and 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
- Batch Record/Device Record Enhancement
- Documentation Enhancement
- Sampling Plans Assessments and Statistical support