EXECUTIVE / ON-DEMAND ADVISORY
Executive
advisory.
Deep analysis.
Strategic decisions.
On-demand FDA intelligence for leadership teams across medical devices, OTC drugs,
cosmetics, foods and dietary supplements.
Analyze Advise Report Retainer
01 / REGULATORY ANALYSIS
Understand.
Move forward.
Clarity on product classification, compliance obligations and U.S. market-entry pathways.
01 / PATHWAYS & RISK
Product Classification & Risk Analysis
We evaluate product design, composition, intended use, claims and supporting evidence to clarify FDA pathways. Depending on the product, we assess labeling, testing, quality-system, registration and listing requirements to identify gaps and risks.
02 / STRATEGIC INSIGHT
Weigh options.
Reduce risk.
Scheduled virtual briefings with lead consultants to discuss findings and next steps.
02 / STRATEGY & ENFORCEMENT
Regulatory Strategy & Risk Mitigation
We help leadership teams weigh regulatory options, address compliance gaps and plan next steps, informed by applicable requirements, FDA enforcement trends, import alerts and relevant precedents.
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; relevant FDA requirements and references; a product-specific analysis of regulatory gaps and risks; and prioritized recommendations. Coverage is tailored to your product category, business objectives and inquiry.
04 / TERMS & SCOPE
Advice when
you need it.
Retainer-based service. The retainer, including any unused balance, expires three years from the initial payment date.
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.