Niraj Shethji

Mr. Niraj Shethji has more than 17 years of research experience working at CROs and Pharmaceutical companies, supporting the early and late phase clinical trials. Before joining Novum, Mr. Shethji served at Sun Pharmaceuticals, Pharma Medica Research, Biovail Corp. and Watson Pharmaceuticals (currently Teva) in variety of roles and increasing responsibilities. He joined Novum in Yr. 2011 to provide scientific leadership to the talented team of scientists, technical writers, statisticians and programmers. In addition to his broad experience with the conventional oral dosage forms (solid/liquid), he gained wide-spread exposure to the design and conduct of the biostudies for complex dosage forms such as transdermal, topical (including corticosteroids), injectable, nasal/inhalation, vaginal/rectal products.

Mr. Shethji has hands on experience in developing study designs and protocols for the NDA/ANDA/505b2 submissions, statistical evaluation/presentation of data and generating high-quality study reports. Mr. Shethji’s diverse experience in fields of PK, PD, bioanalysis, biostatistics, efficacy trials and regulatory sciences assists in directing Novum team in day-to-day functions and guiding clients in their development/submission strategies. He has been greatly involved with Novum’s project management in providing the scientific and operational support to meet client’s expectations. Mr. Shethji received Masters of Pharmacy (Pharmacology) and BS in Pharmacy from University of Pune.