Pharmaceutical and Medical Regulations Experts
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.
Regulatory submissions and applications, including:
- Clinical Trial Applications (CTA)
- New Drug Submissions (NDS)
- Investigational Testing Authorizations (ITA)
- Medical Devices Licence Applications (MDLA)
Regulatory Life Cycle Management activities, including:
- Supplemental New Drug Submissions (SNDS)
- Notifiable Change (NC)
- Annual Drug Notification (ADN)
- Yearly Biologic Product Report (YBPR)
Additional regulatory services related to drugs, biologic, biotechnological, medical devices, vaccine, veterinary, natural health, generic and biosimilar products
Product Monograph, 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
50 years of expertise
Our team has over 50 years of combined experience in regulatory affairs and product development, it has contributed to obtaining numerous clinical trials and marketing authorizations for drugs and medical devices.