Dr. Bernard A. Olsen
Olsen Pharmaceutical Consulting, LLC
1020 Kingswood Rd W
West Lafayette, IN 47906
Phone:
(765) 414-4459
E-mail: bolsen@comcast.net
Specialties:
- Analytical chemistry and method development
- Pharmaceutical development with a focus on CMC
- Experienced expert witness for patent litigation
Services:
AAPS Fellow with over 30 years of experience at Eli Lilly and Company in Chemistry, Manufacturing, and Control aspects for all phases of drug development, particularly for synthetic molecules.
Please see CV for complete background. CV in pdf format.
Specific areas of experience and services offered include:
- Analytical method development and validation
- HPLC and other separation methods
- Chiral analysis and method development
- Impurity investigation and control
- Genotoxic impurity (GTI, PGI) assessment and control
- Regulatory filings (CTD, IND, NDA, DMF)
- Specification setting
- API physical property evaluation and control
- Expert witness for patent litigation
- Technology transfer
- Forced degradation and stress studies
- Drug stability
- Residual solvents methods and specifications
- Pharmacopeial (USP, PhEur) testing
- Due diligence assessments
