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
