Expert Profile
Contact Info:
Email: r ***** @ ***** . com
Office phone: + *****
Cell phone: + *****
Website: www. ***** . com
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Expert Profile:
** Pharmaceutical industry entrepreneur/expert whose experiences include the successful delivery of outsourced clinical data management group created for Pfizer ***** in India (Central Research, Groton, T) via the start-up presence in the 1990s.
**Founder-CEO of ***** . ***** delivers US FDA regulatory compliance consulting & GMP assessments and Gap analysis, training & other services to the pharmaceutical and biotech industry in the US, Asia. (India & China), and other BRIC regions.
**We specialize in emerging regions for the biotech and pharmaceutical industry. Pharmerging regions we serve include India, China, South Korea etc. with GCP, GMP consulting, US FDA grade inspections, gap assessments etc. We operate out of New York but have an office in India.
** Technology (SmartInspect) option allows our pharma customers to join remote but in real-time via wireless, mobile telepresence over Internet using video/audio wearable conferencing system to assist big pharma like Pfizer and Bristol Meyers Squibb with global supply chain quality system management/audits and technology transfer, remote diagnostics, etc.
** See www. ***** . com for more information on SmartInspect- ***** ’s wearable, wireless technology NOW being used to assist big pharma with manufacturing supply chain & GMP compliance.
CEO-Founder
***** *****
Privately Held; Pharmaceutical Services, Computer Software industry
December 2007 – Present
New York, USA and Mumbai-India
CEO-Founder - ***** *****
www.*****.com
Company Profile:
* ***** performs US FDA on-site and virtual mock inspections using its SmartInspect technology. www.*****.com - Click "SmartInspect' human figure.
* ***** assists Western (US and Euro) biopharma , SMEs, medical devices companies create new markets in Emerging Regions (BRIC) with focus in India & China.
Qualifications & experiences include:
•***** ***** is a US based company operating with its presence in India -we assisted worlds largest pharmaceutical company, Pfizer establish an outsourced clinical data management group in Mumbai, India in 1993.
We understand and operate with Western business best practices/mindset while navigating local cultures.
• Our focus is EMERGING REGIONS in the pharmaceutical and biotech industry.
***** is a pharmaceutical, management consulting company that assist others to grow pharmaceutical markets in emerging or developing regions.
** Products and Services the ***** delivers:
• Assist foreign companies with US FDA regulatory matters to include DMF filing, US FDA consulting services on GCP/GMP, etc.
• Assist US and other Western companies with researching and establishing new markets in India. Our past client include US Pfizer Clinical Research Division, Groton, CT, RSE (API China), etc.
•Create APAC countries gain a foothold with their products and services in India markets
• 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,
www.*****.com/smartinspect
• ***** 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
Past Events:*****/events/pharma-anticounterfeitinglalit.html
www.*****.com/events/ma/globalindianma.html
***** *****
Privately Held; Computer Software industry
BS Chemisty, St. Louis University
MBA- Operations Research/Statistics
ISPE
www.*****.com/events/ma/globalindianma.html
www.*****.com/events/pharma-anticounterfeitinglalit.html