Malini Batheja, Ph.D.

Senior Analytical Services Consultant

Dr. Batheja has over twenty years of experience in managing research and development analytical labs in pharmaceutical companies including managing CMO activities all over the world (China, India, Europe, and US). She was responsible for starting up analytical labs in three different companies and supervised 25-30 chemists in different organizations. Expertise in development and validation of analytical methods for peptides, large and small molecules. Authored the CMC section for Module 3 of 4 NDAs and 25 ANDAs including PAI inspections for FDA, EMA, and Health Canada.


Core Competencies

  • Analytical Strategy
  • Method Review
  • Method Authoring
  • Method Validation
  • Design of Experiments
  • CMO Selection
  • Tech Transfer
  • Stability Protocols
  • Peptides