Issue of the Month

Regulatory insights from EAS Consulting Group consultants.

Each month, EAS Consulting Group publishes an Issue of the Month examining emerging regulatory developments, compliance challenges, and quality system insights across FDA-regulated industries.

These articles are written by EAS consultants and industry specialists with decades of experience supporting companies in food, dietary supplements, pharmaceuticals, medical devices, tobacco, and related sectors.

Topics frequently explored include food safety systems, inspection readiness, regulatory strategy, and emerging industry risks such as why food recalls are increasing.

New this month

Featured Insight

FSVP Tips to Navigate Common Pitfalls

This Issue of the Month provides practical guidance for companies implementing the FDA’s Foreign Supplier Verification Program (FSVP), outlining common compliance pitfalls and steps importers can take to strengthen documentation, supplier oversight, and food safety compliance.

Read the full article

Archive of Past Issue of the Month Regulatory Insights

Next Entries »

Issue of the Month

Regulatory insights from EAS Consulting Group consultants.

Featured Insight

FSVP Tips to Navigate Common Pitfalls

Archive of Past Issue of the Month Regulatory Insights

Drug Master File Submissions – An Overview

FDA’s Design Control Requirements for Medical Devices

FSMA and Dietary Supplements

What Makes a Good Sampling Plan?

The Purpose of a DEA Regulatory Investigation

What Are Medical Foods (and What They are Not)

Getting to Grips with the electronic Common Technical Document (eCTD) Process

New Drug Development in the 21st Century

Preparing for FDA Foreign Drug Inspection

When Should a Drug Compounder Register as an Outsourcing Facility?

FDA’s New Medical Device Regulations

Corporate Culture Meets FSMA Compliance at the Intersection of Food Safety

When the FDA Inspector Wants to Take Photographs

Welcome to Europe!

Verifying Label Claims “By Input” Unacceptable

FDA’s Generic Drug User Fee Act (GDUFA) – Drug Master Files (DMFs)

The Importance of Food Recall Readiness

Expediting FDA Approval of Sunscreen Ingredients

FDA to Enforce New Infant Formula Rules Immediately

Follow-Up to the July Issue of the Month

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