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Regulatory Services
Among the many regulatory services we provide, are the following:
Please do not hesitate to contact us if you have any questions, or if you have other needs not included in the above list.
- Regulatory strategy
- Clinical study submissions (CTAs and amendments)
- Drug submissions (New Drug Submissions, Supplemental New Drug Submissions, Notifiable Changes) for pharmaceuticals and biologics
- Co-ordinating and organizing pre-NDS or pre-CTA meetings with Health Canada
- Medical device submissions
- Natural Health Product submissions
- Chemistry and manufacturing changes
- Product monograph, package insert and package labelling development
- Processing Access to Information (ATI) requests
- Submission support during Health Canada review
- Regulatory dossier assessment and review
Please do not hesitate to contact us if you have any questions, or if you have other needs not included in the above list.