Carexa Incorporated was founded by Jan Sedgeworth in 2003. Carexa enables access to a network of experienced consultants providing strategy and services for drug development and regulatory affairs. The core members of the network are:
NORTH AMERICA
Jan Sedgeworth, PhD has over seventeen years of experience in the pharmaceutical and biotechnology industry. Dr. Sedgeworth has held executive positions in regulatory affairs at SmithKline Beecham, GlaxoSmithKline and Hemosol. Over a period of 8 years with SmithKline Beecham, Dr. Sedgeworth was responsible for the approval of more than 18 New Chemical Entities in Canada in a variety of therapeutic and product areas, including CNS, cardiovascular, diabetes and vaccines. At Hemosol, Dr. Sedgeworth was responsible for world-wide regulatory affairs, focussing on FDA, MCA and Health Canada. In 2003, Dr. Sedgeworth formed Carexa Inc., providing consulting services to the pharmaceutical and biotechnology industries.
Joan C. Pehta, MD is a seasoned medical and regulatory professional in the pharmaceutical industry. Prior to forming the consulting company The Alpha Bio Group in 2000, Dr Pehta was responsible for Clinical and Medical Affairs for 10 years at V.I. Technologies, Inc. where she was instrumental in the clinical development and US licensure of a novel viral inactivated blood product, S/D Plasma. In addition, Dr Pehta directed clinical operations, medical safety, clinical regulatory affairs, and medical marketing. Dr Pehta has extensive experience with the FDA including an in-depth knowledge of regulations for drugs and biologics for human use, and requirements for establishing and maintaining regulatory compliance for the conduct of clinical research.
Lidia Derewlany, PhD has over eleven years experience in the Canadian pharmaceutical industry. Dr. Derewlany has been responsible for securing regulatory approvals in a wide variety of therapeutic areas encompassing both biologic and pharmaceutical products. Dr. Derewlany began her career at Eli Lilly and has held senior Regulatory positions at SmithKline Beecham and GlaxoSmithKline. Dr. Derewlany’s experience includes serving as a representative to the pharmaceutical industry on the APETI (Advisory Panel on the Electronic Transmission of Information) and ACES (Advisory Committee on Electronic Submissions) advisory committees to Health Canada. Dr. Derewlany also holds an appointment as Assistant Professor in Paediatrics at the University of Toronto.
EUROPE
Ulrich Granzer, Ph.D. has held senior regulatory positions at a number of large pharmaceutical companies, including Glaxo/Glaxo Wellcome, BASF Pharma Knoll, and Bayer. As head of regulatory affairs for Glaxo, he was a member of the global regulatory board, and was responsible for European and global drug development, and regulatory submissions. At BASF Pharma Knoll, his areas of responsibility included regulatory affairs, drug safety and GXP. Following his tenure as VP Global Regulatory Affairs at Bayer, he founded his own company, Granzer Regulatory Consulting and Services . He has a track record of working on more than 50 NMEs (small molecules and biologicals) covering a variety of therapeutic areas including HIV, asthma, cardiovascular, CNS, oncology.
Carexa's experts maintain current regulatory knowledge through ongoing contact with regulatory agencies, as well as through active memberships in various industry associations including:
We also offer knowledge management products and services through an affiliation with the Sendar-Menlha Corporation . This includes preparation of electronic submissions in a format acceptable to any major regulatory agency.
A broader network of contacts provides additional resources in other areas, including commercial services and biostatistics.