プロフィール詳細

プロジェクトを作成

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Dr. Brent R.に依頼

United States

I sell FDA Compliant Drug Substance and Drug Product Quality and Performance Testing Programs & Guidance to FDA Approval

プロフィール概要

I own a consulting firm with over 70 years of experience throughout the entire lifecycle of pharmaceutical submissions. We ensure your Drug Substance and Drug Product lifecycle meets FDA compliance standards.

専門分野

• ★ Investigational New Drug (IND) Application Consulting
• ☆ Inorganic Chemistry
• ☆ Natural Product Chemistry
• ☆ Physical Chemistry
• ☆ Polymer Chemistry
• ☆ Analytical Chemistry
• ☆ Deformulation
• ☆ Separation & Purification
• ☆ Spectroscopy
• ☆ Atomic Absorption Spectroscopy
• ☆ Atomic Emission Spectroscopy
• ☆ UV Spectroscopy
• ☆ Fluorescence Spectroscopy
• ☆ IR Spectroscopy
• ☆ Raman Spectroscopy
• ☆ NMR Spectroscopy
• ☆ Circular Dichroism Spectroscopy
• ☆ Spectrophotometry
• ☆ Mass Spectrometry
• ☆ Molecular Imaging
• ☆ Liquid Chromatography/HPLC
• ☆ Thermal Analysis
• ☆ Microcalorimetry
• ☆ Gas Chromatography
• ☆ Particle Size Distribution
• ☆ Optical Rotation
• ☆ Organic Chemistry
• ☆ Physical Organic Chemistry
• ☆ Biochemistry
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cell Culture
• ☆ Stable Isotope Analysis
• ☆ Particle-Induced X-Ray Emission
• ☆ Drug Development
• ☆ Drug Stability Testing
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Management
• ☆ Stability Testing
• ☆ Regulatory Writing
• ☆ NDA/BLA Applications
• ☆ Investigational New Drug (IND) Application Writing

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Business & Legal Writing

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

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Big Data Analytics, Data Processing, Data Insights

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

職務経験

Founder & Managing Member

Brighton Ashford, LLC

3月 2015 - 現在

Commercial Contracts

Pace Life Sciences, LLC

9月 2022 - 2月 2023

Business Development - Subject Matter Expert

Pace Life Sciences, LLC

9月 2019 - 9月 2022

Patent Technical Expert

Haukaas Fortius PLLC

12月 2018 - 6月 2019

Senior Chemist Extractables & Leachables / Trace Impurities

Pace Life Sciences, LLC

3月 2017 - 12月 2018

Chemistry Faculty

University of Wisconsin - River Falls

8月 2016 - 6月 2017

学歴

Juris Doctorate

Mitchel Hamline School of Law

8月 2011 - 5月 2014

Ph.D. Organic Chemistry

South Dakota State University

8月 2003 - 8月 2008

認定資格

• 認定資格の詳細は未入力です。