プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Sterling H.に依頼

United States

Regulatory, Quality & R&D Consultant | Dietary Supplements, Food & Pharma | 21 CFR 111/117, GMP, Product Development

プロフィール概要

I am a Regulatory, Quality, and R&D professional with 15 years of experience supporting the dietary supplement, food, pharmaceutical, and medical device industries. I bring deep expertise across FDA-regulated frameworks, including 21 CFR 111/117/210/211/820. My work includes support for combination products and cross-category compliance strategies. I offer full-spectrum support across the product lifecycle: Regulatory Affairs: FDA and FTC compliance for labeling (Supplement Facts and Drug Facts), structure and function claims, GRAS and NDI submissions, OTC monograph compliance, and global regulatory alignment across the US, EU, LATAM, and Canada Quality Systems: Development and implementation of GMP and QSR programs, audit readiness, change control, and documentation for supplements, drugs, and medical devices R&D and Formulation: Clean-label product development, ingredient safety assessments, formulation scale-up, and delivery system design including hard capsule technologies and functional blends I have partnered with startups, CDMOs, and global brands to bring together science, compliance, and execution. My approach helps teams bring safe, effective, and compliant products to market with clarity and speed. If you need a trusted expert to support regulatory submissions, GMP systems, or product innovation, I provide practical solutions built on real-world experience and regulatory insight.

専門分野

• ★ Regulatory Affairs
• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Nutraceuticals
• ☆ Food Engineering
• ☆ Nutrition Science
• ☆ Food Sensory Analysis
• ☆ Food Safety
• ☆ Flavor & Fragrance Chemistry
• ☆ Food Chemistry
• ☆ Plant-Based Protein
• ☆ Food & Beverage Manufacturing
• ☆ Nutritional Analysis
• ☆ Recipe Formulation
• ☆ Clinical Trials
• ☆ Herbal Products
• ☆ Supplements
• ☆ Innovation Management
• ☆ Project Management
• ☆ Corporate Governance
• ☆ 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, Business & Legal Writing, Copywriting, Creative Writing, Audio Transcription, General Proofreading & Editing, Translation

Research Market Research, User Research, Technology Scouting, Gap Analysis, Scientific and Technical Research

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis, Image Processing, Image Analysis, Algorithm Design-ML, Data Visualization, Big Data Analytics, Text Mining & Analytics, Data Mining, Data Cleaning, Data Processing, Data Insights

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping, Reverse Engineering, Device Fabrication

職務経験

Associate Director, Regulatory Affairs, North & South America

Lonza

5月 2025 - 現在

Associate Director, Quality (R&D)

Lonza

7月 2023 - 5月 2025

Associate Director, Quality

Lonza

5月 2020 - 5月 2023

Quality Engineering Manager

Cardinal Health

2月 2015 - 7月 2020

Sr. Quality Engineer

Medtronic

1月 2013 - 2月 2015

学歴

Master of Science in Quality Assurance

Kennesaw State University

8月 2020 - 8月 2022

Bachelors, Chemistry

Augusta State University

8月 2011 - 12月 2014

認定資格

• 認定資格の詳細は未入力です。