From strategic planning to submission work to complete management of your regulatory needs, MCSI has a plan and solution that is right for your unique situation.

  • Regulatory and strategic planning
  • Organize and manage TPD meetings
  • Prepare and file NDS’s (New Drug Submissions)
  • Prepare and file CTA’s (Clinical Trial Applications)
  • Provincial formulary submissions
  • Rx to OTC switches
  • Label and advertising review
  • Drug Establishment License (DEL) applications
  • Prepare drug master files
  • Prepare Plant Master Files (PMF) and Site Reference Files (SRF)
  • Prepare and file NDA’s (New Drug Applications), ANDA’s (abbreviated New Drug Applications), SNDA’s (supplemental New Drug Applications)
  • Submission support during TPD / FDA reviews

We invite you to contact us!

McCarthy Consultant Services Inc.
14-320 Harry Walker Parkway North
Newmarket, Ontario Canada L3Y 7B4

Phone: 905.836.0033
Fax: 905.836.0006


Let’s Get In Touch

  • Telephone Number