プロフィール詳細

プロジェクトを作成

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Dr. Sandeep P.に依頼

India

Ph.D. in Chemistry with 14 years of experience in regulatory affairs of pharmaceutical products and medical devices

プロフィール概要

Ph.D. in Chemistry having a total of 14+ years of experience in the pharmaceutical industry, expertise in the regulatory intelligence of pharmaceutical/Biologics, medical devices, and tobacco regulations.

専門分野

• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research User Research, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Processing, Data Insights

Product Development Product Validation

職務経験

Regulatory Intelligence Manager

RegDesk Inc.

4月 2020 - 現在

Sr. Associate- Global Regulatory Services

IDS Infotech Ltd

6月 2018 - 4月 2020

Sr. Chemist

Mylan Lab. Ltd.

1月 2012 - 5月 2012

Analytical Scientist

Divakar Lab. Ltd.

11月 2009 - 12月 2011

QA/QC Chemist

Cipla Ltd

4月 2008 - 11月 2009

QC Chemist

Aarti Drugs

6月 2007 - 5月 2008

学歴

Ph.D. Chemistry (School of Chemical Sciences)

North Maharashtra University

6月 2012 - 3月 2018

PhD (Chemistry)

North Maharashtra University, Jalgaon

5月 2012 - 3月 2018

M.Sc. Chemistry (School of Chemical Sciences)

North Maharashtra University

7月 2005 - 5月 2007

MSC Chemistry

North Maharashtra University, Jalgaon

6月 2005 - 5月 2007

BSc Chemistry

North Maharashtra University, Jalgaon

6月 2002 - 5月 2005

認定資格

• ISO 13485:2016 Quality Management Systems for Medical Devices

  Alison

  https://alison.com/shop

  6月 2022 - 現在

出版物

JOURNAL ARTICLE

Sandeep Pawar(2017). Synthesis of Ibuprofen intermediate using alcoholic silver nanoparticles and its kinetics: A greener approach towards drug synthesis . Chemical Physics Letters. 671. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 147--153. Elsevier {BV}

Sandeep Pawar (2016). Gold Nanoparticles Catalyzed Synthesis of Ibuprofen Intermediate in Aqueous Ethanol . Der Pharma Chemica.