+1 (317) 616-8779
steve@baertschiconsulting.com
swbaertschi@gmail.com
Baertschi Consulting is an Indiana-based consulting firm specializing in providing solutions to the most difficult impurity, stability, and formulation issues. We work with small to large companies across the globe, from pre-clinical to post-registration phases.
Providing Consulting Services related to:
- Design, Execution and Interpretation of Stress Testing
- Chemical, Physical, and Environmental Stability/Degradation
- Photostability / Photochemistry
- Analytical and [Mutagenic] Impurity Control Strategies
- Analytical Method Development
- Formulation Design and Stabilization
- Scientific Staff Development
- Global Regulatory Submissions and Issues
- Quality-by-Design
- Legal / Expert Witness / Patent Disputes
- Degradation Predictions using Lhasa’s Zeneth software
- Forced Degradation Critical Analyses for drugs to be submitted to Brazil’s ANVISA (RDC 53/15 legislation)
- N-Nitroso / N-Nitrosamine Impurities and Risk Assessments for the Formulated Product