プロフィール詳細

プロジェクトを作成

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Vandana C.に依頼

India

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

プロフィール概要

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.

専門分野

• ★ Product Compliance
• ☆ Regulatory Affairs
• ☆ Project Management

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Consulting Scientific and Technical Consulting

職務経験

Co-Founder|Operations management

Etica Clinpharm Pvt Ltd

1月 2015 - 1月 2019

Co-Founder|Operations management

Etica Clinpharm Pvt Ltd

1月 2015 - 1月 2019

Manager-Project management

Ethix Pharma

10月 2009 - 12月 2014

Manager-Project management

Ethix Pharma

10月 2009 - 12月 2014

Executive Regulatory Affairs

Macleods Pharmaceuticals Ltd

1月 2009 - 9月 2009

Executive Regulatory Affairs

Macleods Pharmaceuticals Ltd

1月 2009 - 9月 2009

Executive Regulatory affairs

Ciron Drugs and Pharmaceuticals Pvt Ltd

12月 2007 - 12月 2008

Executive Regulatory Affairs

Ciron Drugs And Pharmaceuticals Pvt Ltd

12月 2007 - 12月 2008

学歴

M.Pharma

University Department of Pharmaceutical Sciences, RTM Nagpur University

8月 2005 - 6月 2007

B.Pharm (Pharmacy)

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

2001 - 2005

認定資格

• 認定資格の詳細は未入力です。

出版物

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.