Ram Balani is a CEO/Founder - FDASmart Inc,FDASmart Inc,New york

Ram Balani

CEO/Founder - FDASmart Inc

Organizing Committee

New york

FDASmart Inc


Dr. Ram Balani, CEO/Founder - FDASmart Inc.

Experienced  R&D and pharmaceutical /biotech business development industry entrepreneur/expert whose experiences include:

Successful planning, delivery & management   of  a clinical data group assembled for the world's largest pharmaceutical company today-Pfizer Inc. via the start-up presence  established for this purpose in India during mid-1990s by Ram Balani ( Pfizer Central Research, Groton, CT.-USA)

Established a successful India-China market strategy in 2009 for Beijing based Reed Sinopharm Exhibits (RSE), China’s leading pharma conference organizer. Project culminated in increased market exposure for API industry in India and  launch of SIPP- Sino-India Partnership Pavilion.

Accomplished speaker and presenter in the global pharmaceutical/biotech and medical devices industry with past speaking presentations, webinars on a wide variety of topics including US FDA GMP in Emerging Regions (India-China), Cphi Lunchtime Series presentation (Frankfurt, Germany 2011), etc.

Regular contributor to various pharmaceutical media print and online publications such as ChemOnline Manager (Germany-Europe audience) and blogging on emerging pharmaceutical topics with   Cphi’s Pharma Evolution blogging site.

2007 Founder-CEO of FDASmart Inc. - a pharmaceutical consulting company focused in emerging regions including India, China. FDASmart delivers US FDA regulatory & GMP services, intelligence, consulting & training services to the pharmaceutical and biotech industry in the US and Asia. (India & China).


Medical Research – LIMS (Lab Information Systems) – worked in medical research; performed laboratory assays including Elisa(monoclonal antibodies), proficient with lab instrumentation including spectrophotometer , fluorimeters’, HPLC, etc.

Information Technology – including software programmer/ consultant roles at pharmaceutical companies, i.e. Mallinkcrodt in St. Louis; Oracle, PL/SQL,Fortran, Internet technologies; Certificate on Big Data (Coursera online course)


  • FDASmart performs US FDA virtual mock inspections using its SmartInspect technology.
  • FDASmart assists Western (US and Euro) biopharma , SMEs, medical devices companies create new markets in Emerging Regions (BRIC) -India & China.
  • Assist Big Pharma and small, medium biopharmas (SmartInspect rentals) with REAL-TIME, REMOTE oversight of global supply chain GMP compliance, SmartInspect is a wireless, mobile free roaming, Internet Protocol based conferencing system which Pfizer acquired,
  • FDASmart organizes and hosts bio-pharmaceutical topics webinars and one day on-site conferences in Mumbai-India-past 2 events in India information are shown below with speaker presentations, photos, etc to assist India markets penetration