Specializing in FDA Regulatory Matters

EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.

 

Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North America, Asia-Pacific, UK and EU, EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).

Recent Issue of the Month Articles

Verifying Label Claims “By Input” Unacceptable

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet quality requirements for identity, purity, strength, composition, and limits of potential contaminants. Criteria used to establish that these requirements are met… Read More

Dietary Supplement

From FDA Ombudsman to EAS Consultant

Every Center in FDA, except CFSAN, has an Ombudsman; there is also an Ombudsman in the Office of the Commissioner. I am the only person to have served as the Ombudsman in two different Centers: the Center for Tobacco Products (CTP) for three years and the Center for Devices and Radiological Health (CDRH) for ten… Read More

Tobacco

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

Two years have passed since passage of the Generic Drug User Fee Act (GDUFA). GDUFA is a significant law that introduced new requirements for active pharmaceutical ingredient (API) manufacturers, including fees associated with their Type II drug master files (DMFs), as well as for establishment registrations and for conversion of type II DMFs into Electronic Common Technical… Read More

Recent Blog posts

FDA issues new draft documents related to compounding of human drugs

Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states. Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public… Read More

FDA Press Releases

Tobacco Products Scientific Advisory Committee (TPSAC) Discusses Modified Risk Tobacco Product Applications (MRTPA)

On April 9-10, 2015 the Tobacco Products Scientific Advisory Committee (TPSAC) will meet to discuss modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 smokeless tobacco products: To view the announcement go to http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm434215.htm. Before FDA can issue an order permitting the sale of an MRTP, the agency must refer the application to TPSAC… Read More

Tobacco

GDUFA Comment Period Reopens for Certain Topics

The Food and Drug Administration announced the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation. FDA is seeking additional written comments from all interested parties, including, but not limited to… Read More