Profiles

Founder - Ranjani Nellore, Ph.D., RAC

Ranjani is a pharmaceutical scientist with 15 years of experience in the US and Indian pharmaceutical industry. She has hands-on experience of drug development for new chemical entities (NCEs) in   various therapeutic areas. With a proven track record of setting up departments in large companies, she founded PharMantra in January 2008 to bring her global drug development expertise to assist companies interested in leveraging the India advantage.

 

Education

  • Ph.D. in Pharmaceutical Sciences, University of Maryland, USA
  • Certificate in Clinical Trials Design and Management, University of California Santa Cruz, USA
  • Regulatory Affairs Certification, RAC, Regulatory Affairs Professional Society, USA
  • Experience
  • Establishment of regulatory affairs department for NCE development at Dr. Reddy’s Laboratories Ltd, India
  • Successful submissions of over 20 clinical trial protocols in US, Europe, Canada and India for NCEs in multiple therapeutic areas
  • Broad CMC experience in NCE formulation development and manufacturing at Roche Palo Alto, USA
  • In-depth knowledge of international regulations including GMPs, GLPs and GCPs
  • Customized training programs
  • Several publications and presentations, invited speaker at national meetings and at academic institutes

    • Principal Consultant - Eswari Muthukrishnan, Ph.D.

    Eswari Muthukrishnan is a Pharmaceutical scientist with over 11 years of combined experience in the US and Indian pharmaceutical and biotech industries. She has experience in drug discovery and development of both small and large molecules.

  • Education
  • Ph.D. University of Missouri-Kansas City, Kansas City, USA
  • Certificate in Clinical Trials Design and Management, University of California, Santa Cruz, USA
  • Experience
  • Multiple therapeutic areas; anemia, oncology, diabetes, pain, inflammation
  • Evaluated new product concepts, conducted/supervised screening PK/metabolism for lead compound selections, PK/PD modeling
  • Prepared and submitted 25 GLP-compliant TK reports (FDA)
  • Protocol designs, study monitoring and review of data of 30 toxicology/research studies for biosimilars and new molecules
  • Seven ANDA enabling clinical study reports including PK and statistical analysis and four Phase I clinical PK reports
  • Contributed to four IND applications - nonclinical and clinical overviews and summaries