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, & 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
  • 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

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

Dr. Baertschi was awarded The Albert Nelson Marquis Lifetime Achievement 2018.

The Albert Nelson Marquis Lifetime Achievement Award is an honor reserved for biographees who have demonstrated leadership, excellence and longevity within their respective industries and professions.

Contracts have been established and services provided to more than 60 pharma / biotech / agriscience companies in the last 5 years!

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Stability – Purity – Quality