+1-289-642-2696   |   info@krinslifescienceslab.ca

Regulatory Affairs and Technical Writing

Our regulatory affairs and technical writing services includes but not limited to:

  • Providing support and documentation for Establishment/ Site Licenses for pharmaceutical/nutraceutical as needed in USA/Canada
  • Project Management
  • Preparing application and Submission of Medicinal Product Applications( such as ANDA/ANDS,NDA/NDS) preperation and submission in USA,CANADA, Australia and in emerging market
  • Test Specification
  • Preparing of Analysis Certifications
  • SOP’s writing
  • Preparing Summary Reports and trending of EM for Manufacturing Premises
  • Protocol and report Writing of Analytical Methods