Health Product Regulatory Services
Pharmaceutical and Medical Regulatory Services in Canada
Since 1997, SPharm has provided Regulatory Services in Canada for pharmaceutical, biotechnological, natural health product and medical device companies from all over the world. Our team has over 60 years of combined experience in regulatory affairs and product development, it has contributed to obtaining numerous clinical trials and marketing authorizations for drugs, medical devices and other health products.
Regulatory submissions and applications, including:
01.Clinical Trial Applications
02.New Drug Submissions
03.Investigational Testing Authorizations
04.Medical Device License Applications
Regulatory Life Cycle Management activities, including:
01.Supplemental New Drug Submissions
02.Notifiable Changes
03.Annual Drug Notifications
04.Yearly Biologic Product Reports
Additional regulatory services related to drugs, biologic, biotechnological, medical devices, vaccine, veterinary, natural health, generic and biosimilar products include:
- Product Monographs, Investigator’s and Device Brochures writing
- Provincial Submissions
- Liaison with decision makers
- Review of labelling and of marketing materials
- Interface with PAAB
- Regulatory training and staffing
- Document translation and regulatory / scientific content validation
- Special Access Programme (SAP) support
Find out what SPharm can do for you.
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