Baertschi Consulting is a pharmaceutical consulting firm based in the Indianapolis area specializing in providing….

Providing Consulting Services related to:

  • Design, Execution and Interpretation of Stress Testing
  • Chemical, Physical, & Environmental Stability
  • Chemical, Physical, & Environmental 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

NEW Expanded Services!

  • Solid State Characterization / Form Control
  • Salt and Polymorph Selection
  • Disproportionation
  • Method Validation and Transfer
  • Specification Development
  • CRO Strategies and Management
  • Peptide and Protein Therapeutics
  • API Chemical Process Development
  • Synthetic Route Design / Development
Pharmaceutical Stress Testing Book 1
Pharmaceutical Stress Testing Book 2

Newest Team Member

Marvin M. Hansen, Ph.D, is an independent consultant with expertise in process chemistry and CMC issues in the pharmaceutical industry.  He has 29 years of experience in drug development, including 28 years at Eli Lilly where he was a Senior Research Advisor.  Key areas of expertise include early phase process development (synthetic route design, synthetic route development), development of API and intermediate impurity control strategies, development of the final API crystallization to deliver appropriate API physical properties, and a special emphasis on Genotoxic Impurity control.  He has extensive experience delivering API for clinical trials using both Lilly internal and outsourced external resources.  He also has experience working at the interface of process development and discovery chemistry.  Dr. Hansen received a B.S. in chemistry from the University of Nebraska-Lincoln, and a Ph.D. in organic chemistry from the University of California-Berkeley.

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All Things Stability