Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Canada HC Guidance: Nitrosamine Impurities in Medications
Health Canada: Guidance on Master Files Procedures & Administrative Requirements
Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
Health Canada: Guidance on Nitrosamine Impurities in Medications
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
Canada Guidance: Regulatory Enrolment Process (REP)
Health Canada: Udated Register of Innovative Drugs
Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities
Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes