Drug Products

Over 25 years of experience providing regulatory affairs and pharmaceutical consulting services to companies seeking market authorization in Canada. Pharmaffair has provided companies with efficient drug development pathways and compliance strategies at all stages of the drug approval process:

• Pre-market gap analysis

• Organizing, planning and participation in Pre-CTA and Pre-NDS meetings

• Chemistry and Manufacturing

• Labelling

• Regulatory Submissions (see list below)

• Post-NOC changes

Pharmaffair provides you with regulatory strategies and submissions ranging from prescription and non-prescription pharmaceuticals including biologics/biosimilars to sanitizers with disinfectant claims.

Pharmaffairs offers complete regulatory services for all of the following submissions:

• Clinical Trial Application (CTA)

• Clinical Trial Application Amendment (CTA-A)

• New Drug Submission (NDS)

• Supplemental New Drug Submission (SNDS)

• Abbreviated New Drug Submission (ANDS)

• Supplemental Abbreviated New Drug Submission (SANDS)

• Notifiable Change Submission (NC)

• Drug Identification Number

• Prescription to OTC Switch (Rx to OTC)

Health Canada's Human Drug Submission and Application Review fees as of April 1, 2018 can be found here.