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James E. Carter, Ph.D.
Regulatory Compliance Initiatives, Inc.

James E. Carter is a Principal in the consulting firm Regulatory Compliance Initiatives, Inc. (RCI), and has more than 30 years experience in the pharmaceutical industry including over 18 years as a consultant. RCI was formed in late 2002 and is a consulting firm that is committed to assisting domestic and international companies with US FDA and international regulatory agency GMP, GCP and GLP requirements for drug substances, drug products, nutritional products, medical devices and medical foods. The principals within RCI are Dr. Carter and Sidney B. Rubinstein, B.S., R. Ph.

RCI is capable of writing, assembling and filing Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDAs) in electronic Common Technical Document (eCTD) format with FDA. FDA has acknowledged that RCI successfully filed, in August 2004, the first electronic DMF in Common Technical Document (CTD) format.

RCI is very strong in assisting companies with compliance issues and establishing quality systems, including preparing companies for an FDA preapproval inspection (PAI). We do Active Pharmaceutical Ingredient (API) and finished dosage form manufacturing site audits worldwide. RCI prepares the site for a PAI and concurrently works to write, assemble and file regulatory submissions.

As a consultant, Dr. Carter previously established Omega Pharmaceutical Consulting, Inc. His work as principal of Omega included many functions now contained within RCI. He has helped clients institute Quality Policies, Quality Systems and CAPA initiatives.
  James Carter

Dr. Carter has performed training related to cGMPs for QA and the laboratory and FDA inspections. Over 25 modules are available to assist companies in their compliance initiatives.

From 1982 to 1991 Dr. Carter was with Johnson & Johnson (J&J) and for six of those years was with Janssen. Janssen Pharmaceutica is based in Beerse, Belgium and is the discovery company within J&J. While Director of QA & Technical Services at Janssen, U.S., Dr. Carter contributed to the development and approval of numerous INDs and NDAs. He also developed a strong Quality background and orientation during those years.

Prior to consulting, Dr. Carter was Director of Product Development with Boehringer Mannheim Pharmaceuticals in Maryland. Because Boehringer Mannheim was based in Mannheim, Germany, his job function included a large international component.

Dr. Carter has a BS degree in Chemistry (1966) and an MS degree in Microbiology (1969) from Brigham Young University. He received his PhD in Medicinal Chemistry from the University of Utah in 1975.

James E. Carter CV

A health care consulting firm with clients in North America, Europe, China, India, Japan, South America, Middle East, and Africa.

Helping pharmaceutical, medical device, and nutraceutical companies obtain regulatory approvals by applying
over 100 years combined experience in regulatory activities with CFRs and cGMPs.

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