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

FDA Updates Biosimilar Q&A Draft Guidance

FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.

Read the full article

Archive of Past Issue of the Month Regulatory Insights

What Not To Feed Your Dog

Originally posted on...

Establishing an Effective Environmental Monitoring Program

Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.