Canadex Laboratories has the knowledge working experience with regulatory agencies.

You can count on us to coordinate and prepare the necessary documents required for all regulatory submissions. Support documentation includes: manufacturing process summaries, component process, and personnel flow diagrams, client specific equipment and process validation summaries.

Product delivery and quality assurance are at the forefront of what we do and we constantly update our methods and resources to ensure that all regulatory requirements are met throughout your project.

Our services can include

  • Process validation
  • DIN and NHP submissions
  • Communications with Health Canada and FDA
  • SOP Writing
  • Label approval
  • GMP Audits