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Regulatory Affairs Services
Drug Products
Natural Health Products
Medical Devices
Drug Establishment License (DEL)
Drug Identification Number (DIN)
New Drug Submission (NDS)
Supplemental New Drug Submission (SNDS)
Abbreviated New Drug Submission (ANDS)
Supplemental Abbreviated New Drug Submission (SANDS)
Notifiable Change Submission (NC)
Prescription to OTC Switch (Rx to OTC)
Medical Devices
Natural Health Products
Medical Devices
Medical Device Establishment Licence (MDEL) (required by Health Canada for Class I Medical Devices)
Investigational Testing Authorization (ITA) Applications
Licence Applications for Class II, III, and IV Medical Devices
Licence Amendments for Class II, III or IV (significant changes)
Licence Amendment Fax-back applications (minor changes)
Regulatory Submissions
Post-NOC changes
Natural Health Products
Natural Health Products
Natural Health Products
Site licence
Pre-market analysis and review
Preparation and submission of NHP Applications (Class I, II and III)
Post-approval changes