decrease your
concept to market
regulatory
timeline
CUSTOMIZED FDA SOLUTIONS
Our mature, dynamic consultants offer
a wide range of expertise
FDA TRAINING • On-site management seminars
• Customized cGMP, cGCP and QSR training
• Risk assessment and management workshops
• Post-marketing surveillance program
• QbD for biotech filings
• Critical path initiative
STRATEGIC FDA PLANNING • Reduce concept-to-market time
• Business development within the pharmaceutical drug process
• Prevent recalls
• Insure advertising and marketing compliance
• Guarantee product integrity
• Identify viable candidates for Rx to OTC switch petitions
• Get the most from your user fees
FDA COMPLIANCE COUNSELING • Litigation support
• Manufacturing and scale-up
• Regulatory submissions
• Due diligence audits
• Mock FDA inspections
• Risk assessment and management (Risk Mapping™)
