WellSpring Pharmaceutical

CONTRACT SERVICES: OUR ABILITY IS YOUR SOLUTION

Celebrating 10 Years of Excellence

Clinical Supplies › Resources

Canadian Regulations and Clinical Associations

At WellSpring, we wish to assist you every step of the way. For more information on Canadian clinical supplies, regulations, or other related topics, please see the links provided:

  1. Food and Drugs Act
  2. Food and Drug Regulations
  3. Food and Drug Regulations – Part C: Drugs
  4. Food and Drug Regulations – Part C: Drugs – C.05.005 – Application for Authorization
  5. Guidance for Clinical Trial Sponsors – Clinical Trial Application (CTA)
  6. Guidance for Clinical Trial Sponsors – Clinical Trial Application (CTA)
    – 8.0 Notification (includes shelf life extension)
  7. Food and Drug Regulations – Part C: Drugs – C.05.006 – Authorization
  8. Food and Drug Regulations – Part C: Drugs – C.05.010 – Good Clinical Practices.
  9. Food and Drug Regulations – Part C: Drugs – C.05.011 – Labeling
  10. Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines:
    Manufacture of Drugs Used in Clinical Trials – Labeling
  11. Food and Drug Regulations – Part C: Drugs – C.05.012 – Records
  12. Guidance for Clinical Trial Sponsors – Clinical Trial Application (CTA)
    13.0 Records Related to CTAs and CTA-As
  13. Food and Drug Regulations – Part C: Drugs –
    C.05.014 – Serious Unexpected Adverse Drug Reaction Reporting
  14. Guidance for Clinical Trial Sponsors – Clinical Trial Application (CTA)
    12.3 Adverse Drug Reactions (ADR)
  15. Food and Drug Regulations – Part G: Controlled Drugs Division 1 – General
  16. Food and Drug Regulations – Part G: Controlled Drugs Division 2 –
    Licenses and Licensed Dealers

  17. Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines:
    Manufacture of Drugs Used in Clinical Trials

Associations

WellSpring's Clinical Services personnel are members of numerous professional organizations to ensure they are up to date on all international initiatives. Our continuous learning initiative will ensure we are able to support all your clinical supplies requirements.