Submission of Drug Master Files

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, filing the submissions, and following-up as needed during the submission process.

A Drug Master File (DMF) submission provides detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. The information contained in the DMF may be used to support an IND, NDA, ANDA, another DMF, an Export Applications.

For more information on Drug Master Files, view our White Paper written by EAS Independent Advisor, Albert Yehaskel.