Dr. Manikya Rao Tirumani who heads the regulatory functions at Maiva has 19+ years of experience in the field of Regulatory Affairs. He and his team support drug development, filing/approval and launch management. He has the experience of filing over 200 ANDAs and 4 NDA (505(b)(2)) with USFDA, which covers the portfolio of varied dosage forms i.e., oral solid dosages, injectable, ophthalmic, nasal, pulmonary topical and Transdermal Drug Delivery System dosage forms. In addition, he has experience of regulatory filings in other geographies (CA, PEPFAR & EU).
He has in depth knowledge of pharmaceutical product life cycle management and providing guidance to project management and formulation development teams regarding regulatory agency’s expectations and supporting plant teams’ successful handling of various regulatory audits.
Prior to Maiva, he was associated with RiconPharma, Aurobindo Pharma, Sandoz, Zydus (Cadila Healthcare Limited) and Mylan Laboratories Limited. Manikya holds a Ph.D. in Pharmaceutical Sciences (Pharmaceutical Analysis) from Andhra University, Visakhapatnam.