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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.

Learn how our proven expertise can help reach your objectives faster. Contact us today.