Question 1

What is MoCRA compliance for cosmetics?

Accepted Answer

The Modernization of Cosmetics Regulation Act (MoCRA) requires cosmetics manufacturers and brands to establish GMP systems, product safety documentation, and facility registration with the FDA. We help companies meet these requirements through GMP system setup, label review, and safety substantiation.

Question 2

What GMP requirements apply to dietary supplements?

Accepted Answer

Dietary supplement manufacturers must comply with 21 CFR Part 111, which covers identity testing, in-process controls, label claims verification, and documentation. We help supplement companies build quality systems and prepare for third-party GMP certification audits from NSF and SQF.

Question 3

What is 21 CFR Part 820 for medical devices?

Accepted Answer

21 CFR Part 820 is the FDA regulation for medical device quality systems. As of February 2, 2026 it is titled the Quality Management System Regulation (QMSR) and incorporates ISO 13485:2016 by reference. It covers quality management system development, design controls, risk management, and production process validation. We help device companies build one quality system that meets the QMSR and ISO 13485 together.

Question 4

What FDA regulations apply to food manufacturing?

Accepted Answer

Food manufacturers must comply with FSMA and 21 CFR Part 117, the FDA's Current Good Manufacturing Practice and Preventive Controls for Human Food rule. It requires a written Food Safety Plan built on hazard analysis and risk-based preventive controls (process, allergen, sanitation, and supply-chain), overseen by a Preventive Controls Qualified Individual (PCQI). We help food facilities build these systems and prepare for FDA inspections.

Industries We Serve

Dietary Supplements

Cosmetics

Food

Medical Devices

Drugs and Pharmaceuticals

No Matter Your Industry, Compliance Starts With the Right Partner