Dr. Douglas, Ph.D., MBA, PMP Regulatory Consultant and Compliance Expert
Regulatory Consultant Dr. Douglas is a former FDA regulator specializing in Chemistry, Manufacturing, and Controls (CMC). With over eight years of service at the Agency, his experience includes hands-on research and development, assessments of regulatory filings, and support for ICH quality guideline development.
With a Ph.D. in Analytical Chemistry and direct health authority experience, Dr. Douglas is an expert in analytical procedure development, validation, and transfer. He has developed novel characterization and release methods for a variety of APIs and drug products, including small molecules, peptides, and proteins. In addition to his technical work, he reviewed sponsor and CMO-submitted data and analytical procedures to ensure alignment with regulatory expectations and guidelines. His analytical expertise spans a broad range of technologies, including chromatography, mass spectrometry, spectroscopy, dissolution, and particle sizing. Beyond his analytical work, he has led pharmaceutical manufacturing initiatives to identify and address common deficiencies and lagging practices observed in US domestic manufacturing.
Dr. Douglas’ technical expertise as a seasoned regulatory consultant is bolstered by his ability to communicate complex scientific information with clarity and precision. He has authored numerous scientific publications, deficiency letters to sponsors, SOPs, analytical methods, and has contributed to regulatory guidance and policy communications.
Passionate about creating high-quality, scientifically accurate writing, Dr. Douglas views strong regulatory writing as a critical but often underappreciated part of successful regulatory submissions. He brings an open-minded approach to his work and is comfortable supporting a wide range of therapeutic areas and product types.
Key Expertise Areas:
- Analytical Procedure Development and Validation: Identification and justification of performance characteristics, analytical technology selection, and validation strategies.
- Enhanced Development and Lifecycle Management: Expertise in presenting development data in regulatory dossiers to support manufacturing and analytical changes without requiring post-approval supplements (aligned with ICH Q12 principles).
- ICH Quality Guidelines: Deep understanding of the ICH Q-series and how to tie scientific work back to globally harmonized standards.
- Quality-by-Design (QbD): Experience constructing and presenting design spaces for processes and parameters to enable operational flexibility and improve product quality.
To work with Regulatory consultant Dr. Douglas, please visit our quote page and request him in the description area.