プロフィール詳細

プロジェクトを作成

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Divya G.に依頼

United States

NubGenix is a consulting organization who provide core solutions for your modern medical device and combination product

プロフィール概要

NubGenix mainly focuses to support start up and mid-size medical device, combination products and pharmaceutical organizations. We provide support from early development through post-market phases. We also assist in designing, establishing and execution of complete Quality Management System (QMS).

専門分野

• ★ Medical Device Development
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ Healthcare Quality Improvement
• ☆ Product Development
• ☆ Medical Device Regulatory Writing
• ☆ Technical & Scientific Writing

サービス

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

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Concept Development, Prototyping

職務経験

Founder and CEO

NubGenix Consulting LLC

8月 2021 - 現在

Associate Director, Quality

Takeda Pharmaceutical Company

12月 2017 - 7月 2021

Plant Quality Manager

Becton Dickinson

4月 2016 - 12月 2017

Quality manager

B Braun

9月 2014 - 3月 2016

学歴

Masters in Biomedical Engineering (Medical Device Commercialization Focus)

New Jersey Institute of Technology

8月 2004 - 5月 2006

Instrumentation Technology

Viswesvariah Technology Institute

8月 1999 - 8月 2003

認定資格

• Certified Manager of Quality/Organizational Excellence

  American Society for Quality

  8月 2010 - 1月 2021