
Naran Patel
Accomplishments: • Experience in global development projects (IND) with solid dosage forms, combination products, and injections. • Experience with marketed products (NDAs)... | United States
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Naran Patel’s Emails na****@so****.com
Naran Patel’s Phone Numbers No phone number available.
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Naran Patel’s Location United States
Naran Patel’s Expertise Accomplishments: • Experience in global development projects (IND) with solid dosage forms, combination products, and injections. • Experience with marketed products (NDAs) managing all regulatory aspects including CMC strategies, Ad/Promo and Labeling updates, and Phase IV commitments. • Therapeutic experience in Women’s Health, CNS/Neuroscience, Cardiovascular, and Diabetes • Preparation of electronic submissions to FDA • Develop global working instructions for cross-functional teams • Analytical experience in development and validation of automated methods and robotic systems and implement the use of systems at both domestic and European sites. • Cost effective system implementation o Implementation of automated method for one of the key product allowed six scientists to work on other projects. This resulted in a multifold efficiency gain and significant cost savings. o Implemented a controlled, unique data sheet system for the documentation of routine products’ analyses. The use of data sheets resulted in a uniform and compliant documentation system and increased documentation and reviewing efficiency by over 500%. • 23 years of experience in various areas within pharmaceutical industry Specialties: CMC strategies, Coordinate and preparation CMC submissions for INDs and approval of NDA, Ad/Promo and Labeling reviews, eCTD submissions, QA related activities, Analytical automation
Naran Patel’s Current Industry Gsk
Naran
Patel’s Prior Industry
Basic Formulation
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Purepac Pharmaceutical
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Warner Lambert
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Abbott Products
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Kowa Pharmaceuticals America
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Gsk
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Work Experience

Gsk
Director, Regulatory Advertising and Promotions Policy
Mon Oct 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Kowa Pharmaceuticals America
Director Quality Assurance/Regulatory Affairs
Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Oct 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott Products
Manager, Regulatory Affairs
Sun Apr 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott Products
Associate Manager, Regulatory Affairs
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott Products
Regulatory Affairs Internship
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott Products
Laboratory Automation Administrator
Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott Products
Scientist II
Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Warner Lambert
Associate Scientist; Analytical Technology(R&D)
Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Purepac Pharmaceutical
Quality Control
Fri Jan 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time)
Basic Formulation
Quality Control Chemist
Wed Jan 01 1986 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time)