プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Shivani A.に依頼

India

Clinical Data Management | Regulatory Affairs | Biotechnology | GLP/GxP | Scientific Documentation with 6 years exp.

プロフィール概要

I am a Biotechnology professional with over 6 years of experience in clinical data management, regulatory documentation, scientific research, and pharmaceutical R&D. I have worked with leading organizations, including Labcorp Early Development India and Shreepad Shree Vallabh SSV Phytopharmaceuticals. My expertise includes clinical and preclinical data review, GLP/GxP compliance, scientific and regulatory documentation, quality assurance, literature review, protocol and report writing, data analysis, and laboratory research. I have hands-on experience with HPLC, UV-Vis spectroscopy, formulation development, stability studies, and documentation such as SOPs, Batch Manufacturing Records (BMRs), and Certificates of Analysis (CoAs). My master's research focused on the development and validation of an RP-HPLC method for peptide injectable formulations, while my industry experience includes nutraceutical and phytopharmaceutical product development, preclinical safety documentation, and medical device study reporting. I am also a co-author of a published research article on the bioavailability of liposomal Vitamin C. I provide high-quality scientific writing, literature reviews, regulatory support, data management, technical documentation, and biotechnology consulting. I am committed to delivering accurate, well-researched, and timely solutions tailored to clients in academia, biotechnology, pharmaceuticals, medical devices, and life sciences.

専門分野

• ☆ Biotechnology & Bioengineering
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Regulatory Consulting
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Clinical Data Management
• ☆ Pharmaceutical Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Audio Transcription, General Proofreading & Editing

Research Market Research, User Research, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Manufacturing

職務経験

Reporting Associate

Labcorp Drug Development

7月 2022 - 3月 2026

Research Associate

SSV phytophramaceuticals

9月 2021 - 6月 2022

学歴

Master in Biotechnology

Mumbai University

8月 2019 - 8月 2021

(Biotechnology)

University of Mumbai

2016 - 2021

認定資格

• clinical data managment

  LabCorp Drug Development

  1月 2026 - 現在