プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Deepak D.に依頼

India

Regulatory Affairs Consultant | Expert in FDA 510(k), CDSCO Licensing, ISO 13485 QMS & SaMD Compliance

プロフィール概要

Highly motivated Regulatory Affairs professional with strong expertise in U.S. FDA 510(k) submissions, Indian import licensing (CDSCO), ISO 13485 quality management systems compliance, and Software as a Medical Device (SaMD) regulations. Skilled in preparing and reviewing regulatory documentation, supporting QMS implementation, internal audits, and CAPA management. Proven ability to develop regulatory strategies, conduct technical writing, and collaborate cross-functionally to ensure safety, efficacy, and regulatory compliance of healthcare technologies across global markets. Practical experience includes supporting regulatory submissions for medical devices, pharmaceuticals, and nutraceuticals, backed by a Master of Pharmacy in Drug Regulatory Affairs.

専門分野

• ☆ Biostatistics
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Bioavailability
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ 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
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Regulatory Affairs
• ☆ Medical Equipment & Supplies
• ☆ Vegan Products
• ☆ Non-GMO Products
• ☆ Product Evaluation
• ☆ Material Sourcing
• ☆ Reverse Engineering
• ☆ Supply Chain & Logistics
• ☆ Inventory Control
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Product Design
• ☆ Product Prototyping
• ☆ CAD & 3D Modeling
• ☆ Design for Manufacturing
• ☆ 2D Drawing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Packaging Design
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ User Research
• ☆ Quantitative User Research
• ☆ Qualitative User Research
• ☆ Meta-Research
• ☆ Feasibility Studies
• ☆ Technology Scouting
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ SEO Medical Writing
• ☆ Continuing Medical Education (CME) Materials
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Cochrane Reviews
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Medical Copywriting
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Copywriting
• ☆ Emails & Newsletters
• ☆ Marketing Copy
• ☆ Social Media Copy
• ☆ Web Copy
• ☆ Blog Posts
• ☆ Public Relations Writing
• ☆ Product Descriptions
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Formulation
• ☆ Cosmetic Formulation
• ☆ Pharmaceutical Formulation
• ☆ Cosmetic & Skincare Formulation
• ☆ Hair Care Product Formulation
• ☆ Personal Care Product Formulation
• ☆ Cosmetic & Personal Care Product Manufacturing
• ☆ Herbal Products
• ☆ Nutraceuticals
• ☆ Supplements
• ☆ Essential Oils
• ☆ Consumer Products
• ☆ Business Operations
• ☆ Business Strategy
• ☆ Business Statistics
• ☆ Business Education
• ☆ International Business
• ☆ Public-Private Partnership
• ☆ Small Business
• ☆ Entrepreneurship
• ☆ Business Intelligence
• ☆ Project Management
• ☆ Risk Management
• ☆ Six Sigma
• ☆ Management Consulting

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription

Research Market Research, User Research, Meta-Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Legal Consulting

Data & AI Image Analysis, Algorithm Design-Non ML, Data Mining

Product Development Formulation, Deformulation, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Associate, Regulatory Affairs

Satori One Click Solutions LLP

1月 2025 - 現在

Master thesis project

Amity University, Noida, India

7月 2024 - 5月 2025

Master Degree Internship

Amity University, Noida, India

8月 2023 - 12月 2023

学歴

Master in Pharmacy

Amity Institute of Pharmacy, Amity University Noida

8月 2023 - 6月 2025

Bachelor in Pharmacy

Lachoo Memorial College of Science and technology Jodhpur

7月 2019 - 7月 2023

認定資格

• 認定資格の詳細は未入力です。

出版物

BOOK

Navneet Sharma, Vikesh Kumar Shukla, Sandeep Arora (2025). Understanding Pharmaceutical Standards and Regulations . Routledge.