Since 1997, SPharm has assisted pharmaceutical, biotechnological, natural health products and medical devices companies from all over the world to comply with the current regulations in Canada and abroad. SPharm also provides training services for individuals or teams needing to learn about the drug review and approval process and other regulatory matters.
Our course materials are developed in-house and are constantly updated to keep current with industry practices and changing regulatory environments. The training we provide include real-life examples with case studies and hands-on exercises to illustrate concepts.
We offer both custom and standard training sessions. Some of the modules we train on include:
- Drug Regulations in Canada and Overview of Health Canada
- The Common Technical Document
- Clinical Trial Regulations
- New Drug Submissions (Standard, Priority, NOC/C, Exclusivity)
- New Drug Submissions (Biologics, Generics, Subsequent Entry Biologics)
- New Drug Submissions (Fees, Time for Reviews, Appeals)
- DIN Submissions
- Changes Post NOC
- Pharmacovigilance (Regulations, Guidelines, Inspections)
50 years of expertise
Our team has over 50 years of combined experience in regulatory affairs and product development. Contact us to discuss your training requirements.