Health Canada can send requests like Screening Deficiency, Clarifax and Notice of Non-compliance to the applicants for additional information/clarification on the content that has been submitted in the ANDS/DIN Application/MF, so that the technical review shall be completed and approval shall be provided. Response to the HC deficiency letters should be submitted on time with sufficient data with suitable scientific justifications to receive the approval within short timelines.
Inadequate response with incomplete supporting documents and lack of scientific justification may lead to another set of queries, which will delay the approval of the product. Hence, it is very important for the applicants to adequately respond to HC queries in short timelines. Freyr, with strong expertise in generics registration activities, can provide complete support in Health Canada query management along with submission of complete response to HC.
Thorough review of the deficiencies received from HC against registered content
Preparation of an action plan
Preparation of response strategy and guidance to the applicant on activities to be performed
Assessment of additional data and or inputs received from ANDS applicant and identifying the gaps
Preparation and submission of response package with scientific justifications and supporting documents
Correspondence with HC/Guidance for extension request and negotiation on the strategy (if necessary)