© 2017 by Maky Zanganeh & Associates

Deepa Deshpande has over 22 years of experience in Regulatory Affairs in the pharmaceutical industry covering clinical, non-clinical and CMC matters.  Deepa has technical expertise in drug-device combination products, biosimilars, controlled release therapies, inhaled therapeutics, fixed dose combination, oligonucleotide/gene therapy, controlled substance and small molecule therapeutics. She has in-depth experience in IND/CTX/NDA/NADA/DMF filings, orphan drug/fast track designation and SPA negotiations and in negotiating with U.S. and EU regulatory authorities. She has been an advisor/FDA liaison for more than 55 pharmaceutical and biotechnology programs ranging from pre-IND through approval.

 

Deepa is the founder and President of Universal Regulatory, Inc. and currently leads a team that provides Regulatory consulting services.  Previously, she held senior management positions of increasing responsibility with Fourteen 22, Inc., Regulatory Professionals Inc., Cerexa Inc., Acologix Inc., and Aradigm Corporation.

 

Deepa earned her Bachelor’s degrees in Pharmaceutical Sciences from Bombay University and her Master of Science and Doctor of Philosophy degrees in Pharmaceutical Sciences at West Virginia University.  In addition, she is RAC certified.  Deepa is the recipient of several honors and awards including Chair of BIOTECH Section of American Association of Pharmaceutical Scientists, Secretary/Treasurer of BIOTECH Section of American Association of Pharmaceutical Scientists, Research Award by American Association Pharmaceutical Scientists (1995). Deepa has served as chairperson and speaker at several workshops, symposia on topics related to regulatory affairs, pharmaceutical development and professional development topics such as achieving successful careers as women in pharmaceutical sciences. She has published extensively in the field of pharmaceutical development.