We specialize in mid-market companies with $5M–$100M revenue who need professional compliance support without enterprise-level costs. Every industry has unique regulatory requirements — we know them all.
Pharmaceutical companies face some of the most rigorous FDA oversight in any industry. From raw material qualification to final product release, every step requires documented compliance with current Good Manufacturing Practices.
ADF provides continuous monitoring of your cGMP systems, documentation practices, and quality controls — ensuring you're always prepared for both announced and unannounced FDA inspections.
Medical device manufacturers operate under the Quality System Regulation with design controls, production controls, and post-market surveillance requirements that demand meticulous documentation and process validation.
ADF helps device companies maintain QSR compliance across the full product lifecycle — from design inputs through manufacturing, complaint handling, and CAPA management.
The regulatory landscape for compounding pharmacies has intensified dramatically. 503A and 503B facilities face increasing FDA scrutiny around sterility assurance, beyond-use dating, and facility controls.
ADF provides specialized compliance support for compounding operations, including sterile processing oversight, environmental monitoring programs, and preparation for state board and FDA inspections.
Dietary supplement manufacturers face growing FDA enforcement around cGMP compliance, label claims, and identity testing. The days of light-touch regulation in this sector are ending.
ADF helps nutraceutical companies build robust quality systems that satisfy both FDA expectations and increasingly demanding retailer audit requirements.
CMOs and CDMOs face a unique challenge: maintaining compliance across multiple clients, multiple products, and often multiple regulatory frameworks simultaneously. A single audit finding can impact every client relationship.
ADF provides multi-client compliance coordination, ensuring your quality systems satisfy the requirements of every product you manufacture — and every customer who audits you.
FSMA transformed food safety regulation from reactive to preventive. Food and beverage manufacturers must now maintain preventive controls plans, supply chain programs, and documented hazard analyses — with FDA inspections to verify compliance.
ADF helps food manufacturers build and maintain FSMA-compliant programs that satisfy both FDA expectations and the third-party audit schemes (SQF, BRC, FSSC 22000) that retailers increasingly require.
If your company is subject to FDA oversight, we can help. Schedule a call and we'll discuss your specific regulatory requirements.