EXECUTIVE / ON-DEMAND ADVISORY
Executive
advisory.
Deep analysis.
Strategic decisions.
On-demand FDA intelligence and risk analysis for leadership teams
navigating regulatory decisions and market entry.
Analyze Advise Report Retainer
01 / REGULATORY ANALYSIS
Understand.
Move forward.
Detailed insight into FDA classification and market-entry pathways.
01 / PATHWAYS & RISK
Product Classification & Risk Analysis
We assess formulations, active ingredients, mechanisms of action and intended use to clarify FDA pathways. Labels, claims and positioning are compared with warning letters, precedents and industry standards to identify compliance gaps.
02 / STRATEGIC INSIGHT
Refine claims.
Reduce risk.
Scheduled virtual briefings with lead consultants to discuss findings and next steps.
02 / CLAIMS & ENFORCEMENT
Claim Optimization & Regulatory Intelligence
We recommend compliant claims and alternative wording that preserve commercial value while reducing risk, informed by relevant FDA enforcement trends, import alerts and industry directives.
03 / EXECUTIVE REPORT
Analysis for
decisions.
Each inquiry receives an Executive Advisory PDF report of up to 8 pages.
03 / REPORT CONTENTS
From Findings to Recommendations
Your report includes an executive summary; FDA laws, guidance and standards; an itemized formulation, claims and labeling risk matrix; risk-mitigation and positioning recommendations; corrective steps; and precedents, warning letters and references.
04 / TERMS & SCOPE
Advice when
you need it.
Retainer-based service. From the initial payment date, unused balances never expire.
04 / SERVICE SCOPE
Focused on Your Inquiry
Guidance and analysis cover your specific questions. Further detailed review, document drafting, regulatory strategy development, submission support, FDA representation and task-specific execution require a separate written proposal and agreement.
CONTACT US
Plan your
next decision.
Discuss your regulatory challenges with PCG for in-depth analysis and strategic guidance on your next decision.