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Profile Details

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USD 100 /hr

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Hire Vandana C.

India

USD 100 /hr

DRA & Patent Consultant| Project management in CRO with 11 yrs of experience in Project lifecycle , Audit & Reg filing.

Profile Summary

Experienced leader with a demonstrated history of global project management in the CRO with over 9 yrs of successful experience in Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, and Team Management with significant experience in regulatory compliance, governance, and Pharmaceutical Legislation - IDMP, xEVMPD, EudraVigilance, EDMS, RIMS and development experience of Regulatory Intelligence Platform, Patent paralegal activities.

Skilled in Nonclinical safety development, Clinical, and Regulatory Affairs, and Product Life cycle Management and knowledgeable about registrations, audits, inspections, and regulatory proceedings.

Special skill in managing complex documentation, reports, and data for regulatory reporting and compliance. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Consistently saved costs while increasing profits.

Subject Matter Expertise

Services

Writing
Research
Consulting

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Consulting Scientific and Technical Consulting

Work Experience

Co-Founder|Operations management

Etica Clinpharm Pvt Ltd

January 2015 - January 2019

Co-Founder|Operations management

Etica Clinpharm Pvt Ltd

January 2015 - January 2019

Manager-Project management

Ethix Pharma

October 2009 - December 2014

Manager-Project management

Ethix Pharma

October 2009 - December 2014

Executive Regulatory Affairs

Macleods Pharmaceuticals Ltd

January 2009 - September 2009

Executive Regulatory Affairs

Macleods Pharmaceuticals Ltd

January 2009 - September 2009

Executive Regulatory affairs

Ciron Drugs and Pharmaceuticals Pvt Ltd

December 2007 - December 2008

Executive Regulatory Affairs

Ciron Drugs And Pharmaceuticals Pvt Ltd

December 2007 - December 2008

Education

M.Pharma

University Department of Pharmaceutical Sciences, RTM Nagpur University

August 2005 - June 2007

B.Pharm (Pharmacy)

Vidarbha Youth Welfare Society's Institute of Pharmaceutical Education and Research

2001 - 2005

Certifications

Certification details not provided.

Publications

JOURNAL ARTICLE

(2012). Evaluation of Efficacy and Safety of AVCO Acne Gel for Acne: An Open, Single Centric, Non Comparative Study for 8 weeks. Asian Journal of Pharmaceutical and Clinical Research.

(2008). High Performance Thin Layer Chromatographic Method for Estimation of Bisoprolol Fumarate in Pharmaceutical Preparations. Journal of Research in Chemistry.

(2008). Spectrophotometric Method for Simultaneous Estimation of Amlodipine Besylate and Bisoprolol Fumarate in Pharmaceutical Preparations. Research J. Pharm. and Tech.

MAGAZINE ARTICLE

(2008). High Performance Thin Layer Chromatographic Method for Simultaneous Estimation of Amlodipine Besilate and Bisoprolol Fumarate in Pharmaceutical Preparations. THE PHARMA REVIEW.