Pharmaceuticals - , ,
Utilizing over 25 years of hands-on analytical development experience in basic research, non-clinical development, API physical and chemical characterization, drug product development and stability, knowledge of domestic and global regulations, MSJ Analytical Consulting Services, LLC provides advice on all aspects of analytical methods development and validations, including development of appropriate specifications and acceptance criteria for non-clinical studies, clinical release and stability, registration stability, marketing authorization process validation studies and analytical technology transfers. MSJ Analytical Consulting Services, LLC provides assistance in the preparation of CMC sections for all types of domestic and global regulatory submissions, support all domestic and global regulatory inspections and provide timely assistance in responding to regulatory questions.