FDA consulting
services that
exceed your expectations
OUR FDA CONSULTING SERVICES
Expertise to ensure you reach your FDA goals
SERVICES • Regulatory strategic planning and development
• Crisis
management and risk assessment (Risk Mapping™)
• cGMP enhancement Master Plan (GEM Plan™)
• Critical path opportunities for generic drug manufacturers
• Compliance support
• Fast-tracking
• Litigation support
• Manufacturing and scale-up management
• Process capabilities and controls (PC&C)
• Regulatory submission preparation - IND, NDA, PMA, BLA
• Due diligence audits
• Mock FDA inspections
• Pre-approval inspection readiness
TRAINING SEMINARS • Quality by Design (QbD) for Biotech Filings
• New Medical Device Regulations - QSR
• Crisis Management and Risk Assessment
• Tech Transfer
• Change Management: A Critical Compliance and Quality System
• The Future of Post-Marketing Surveillance
• The Art of Compliance and Beyond: 12 Critical Programs
• GMPs: A Current Perspective
• GCPs: FDA's Current Expectations
We offer on-site, customized personnel and management training.
