Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 225 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Brent R.

United States

USD 225 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

Founder & Managing Member

Brighton Ashford, LLC

March 2015 - Present

Commercial Contracts

Pace Life Sciences, LLC

September 2022 - February 2023

Business Development - Subject Matter Expert

Pace Life Sciences, LLC

September 2019 - September 2022

Patent Technical Expert

Haukaas Fortius PLLC

December 2018 - June 2019

Senior Chemist Extractables & Leachables / Trace Impurities

Pace Life Sciences, LLC

March 2017 - December 2018

Chemistry Faculty

University of Wisconsin - River Falls

August 2016 - June 2017

Education

Juris Doctorate

Mitchel Hamline School of Law

August 2011 - May 2014

Ph.D. Organic Chemistry

South Dakota State University

August 2003 - August 2008

Certifications

• Certification details not provided.