Stewart J. Ehrreich, Ph. D.
Regulatory Consultant

download Dr. Ehrreichs complete CV.

After receiving his doctorate in pharmacology, Dr. Ehrreich spent two years as a postdoctoral fellow after which he was employed for twelve years in the pharmaceutical industry. His main area of specialization was the discovery and development of drugs for cardiovascular disease. Following his industrial experience, Dr. Ehrreich joined the FDA where his last position was as Deputy Director of the Division of Cardiorenal Drugs. He was responsible for the review and evaluation as well as approval of new drugs and blood substitutes as well as TPA.

Dr. Ehrreich's skills span the areas of drug research and regulation. He spent ten years consulting with companies whose major objectives were the submission of successful INDs NDAs 510 (k)s and PMAs, not only in the cardiovascular area but in the other disciplines regulated by FDA. His current clients are being assisted in the following drug areas: AIDS, antidepressants, cardiovascular, endocrine, biotechnology products, wound healing, and anticancer drugs, among others. He has extensive experience with generic drugs, ANDAs for topical and systemic use, and OTC drug evaluation. He has close ties to FDA personnel and visits FDA on a regular basis to keep up to date with the latest information that would be valuable to clients. Dr. Ehrreich's marriage of industrial and regulatory know-how is unique and clients are using his services not only to preclude FDA issues but also to solve tough scientific/clinical/regulatory issues which arise post-submission.

Assistance is also given to help select compounds before IND stage and to help prepare regulatory documents which are as trouble-free as possible. Dr. Ehrreich is prepared to explain the FDA process as well as help individuals through the difficulties which often occur at the various stages from IND to NDA. Dr. Ehrreich's main responsibilities at FDA were the review of preclinical toxicology and clinical portions of submissions and helping sponsors with the clinical development of their drugs. His interest in preclinical toxicology has also helped potential sponsors develop the proper toxicology trials before the submission of an IND or IDE, NDA or PMA. Dr. Ehrreich's Device experience includes work inside/outside FDA on blood substitutes, bone cements, anesthetic devices, contraceptive devices/delivery systems and diagnostic devices. He is currently working on two drugs to be used in cancer patients and a new drug for hair growth. His mentor, Dr. Robert Temple, recently revised the Device regulations and Dr. Ehrreich is thoroughly familiar with these. He has also worked with Dr. Susan Alpert on various projects.

Dr. Ehrreich has also helped sponsors develop plans for drug advertising pieces as well as providing help with the acquisition of reasonable compounds for the U.S. market. The latter includes evaluations of prospective candidates' chances for FDA approval. Dr. Ehrreich's main scientific interests are the toxicology of cardiovascular drugs. He has published many papers in this area as well as book chapters. He has also given lectures on regulatory issues and how to prepare INDs, ANDAs and NDAs. He has also acted as a GLP auditor and inspector while at FDA and in his capacity as a regulatory consultant.