Specialties: Regulatory

Albert Yehaskel is an independent consultant with EAS Consulting Group, LLC, who has over 47 years of experience in the Pharmaceutical industry. He is an experienced and accomplished pharmaceutical professional with a distinguished record of achievement and success in the management of regulatory affairs.

Following 17 years of medicinal research, he subsequently entered the area of Regulatory Affairs, international and domestic, gaining valuable global regulatory experience. He has worked for Lederle Laboratories (American Cyanamid) now known as Wyeth, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO Pharmaceuticals. He has devoted over 30 years to Regulatory Affairs, managing and directing domestic and international Regulatory Submissions, orchestrating key FDA meetings and conducting Pharmaceutical Research and development.

While at Sankyo, he filed and obtained approval of two electronic NDAs whose products (Benicar and Benicar/HCT) are currently on the market. He has also filed numerous IND applications, amendments, supplements, Special Protocol Amendments, Labeling and other Regulatory documents with FDA. Albert enjoys and likes the challenge of electronic submissions, both NDAs and INDs.  Albert also worked for Shionogi USA, a prominent, Osaka, Japan-based company, where he challenged himself to apply his Regulatory knowledge and knowledge of Japanese business.

Albert has interacted with over 13 different divisions at FDA (CDER, CBER, CDRH), orchestrating and participating in teleconferences and face-to-face meetings such as pre-IND, guidance meetings, EOP2 meetings, pre-NDA meetings and meetings with the Carcinogenicity Assessment Committee.

Albert has built, managed and mentored regulatory teams as well as creating regulatory and quality infrastructures in companies that did not have any. He has written many SOPs and provided in-house training.