FDA Regulatory and Compliance Experts
Guiding innovative and leading medtech businesses since 2018.
Amory Consulting, LLC leverages evidence-based data and regulatory intelligence to lead domestic and international businesses across complex regulatory landscapes. Our tailored, total product lifecycle support spans development, regulatory strategy, approval, compliance, and post-market activities, aligning regulatory requirements with business objectives. By translating FDA developments into clear operational, strategic, and compliance implications, we enable organizations to make informed decisions and execute with confidence.
Contact Us
info@amoryconsultingllc.com
We are an east coast based team.
Services
Product Development and Authorization
Successfully navigating the regulatory process requires strategic judgment—knowing when to challenge, when to collaborate, and when to pivot. Our team includes industry and former FDA professionals with experience guiding FDA-regulated products to market.
We support clients through the total product life cycle, from preparing for and participating in agency meetings to identifying the data needed for marketing authorization.
Compliance and Quality
We have worked in industry and at FDA and are familiar with balancing compliance and business needs. We identify next steps that address FDA concerns, protect public perception, and minimize business interruptions.