All information and material and responses to clarification requests
to be sent via courier to the Submission and Information Policy Division (SIPD)
Atinza can prepare package and sent to SIPD on behalf of clients. We will also control the dispatch of documents and following the process of evaluation by Health Canada. We will also response to Notices (including Screening Deficiency Notices, Notices of Non-Compliance, Notices of Deficiency) on behalf of clients.
CTAs, CTA-As
to be sent via courier to the appropriate Bureau/Centre, Biologics and Genetic Therapies Directorate or Therapeutic Products Directorate.
Atinza will support clients to ensure compliance with “Guidance for Clinical Trial Sponsors – Clinical Trial Applications“. We will also control the dispatch of documents and following the process of evaluation by Health Canada. We will also response to Notices on behalf of clients.