Assistance with FDA Inspections

EAS consultants offer the best in Pharmaceutical Good Manufacturing Practices (GMP) compliance audits and facilitate an understanding of how to implement quality programs that meet FDA expectations. FDA ensures the quality of pharmaceuticals in the US marketplace through a system of GMPs, providing a ...

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filin...

EAS provides a variety of FDA based regulatory services to the global Rx and OTC pharmaceutical industry.We offer a seamless approach to help your organization navigate the regulatory intricacies associated with product development, submissions, claims and labeling,manufacturing and packaging of commercial products,as well as facility and product registrations and listings. Our team of pharmaceutical regulatory experts are ready to provide assistance in; the development of filing and quality strategies, GMP/GLP/GCP assessments, Mock-FDA Inspections and reviews, quality management system development, regulatory submissions, product labeling and claims compliance, and a number of other topics  that will help your organization succeed in this highly complex and very competitive regulatory environment. EAS is committed to helping the members of domestic and international pharmaceutical market understand,meet and sustain compliance with the FDA’s numerous requirements in a manner t