EMA or other EU Health Authorities might need clarification or additional information to complete the technical review of the content that has been submitted to HAs through various procedures, which would be requested to MAH as day 120/150/180/210 queries. These queries should be addressed timely with scientific inputs/justifications, as the review cycle will be on hold until the response. Also, inadequate response to the queries will lead to a further round of queries and delayed approval of the Marketing Authorization Application (MAA).
Freyr has extensive experience in handling MAA submissions approval to EU countries for all types of formulations.
Thorough review of the deficiencies received from EMA/other EU HAs against registered content
Preparation of action plan with responsibilities to meet the response submission timelines
Preparation of response strategy and guidance to the applicant on activities to be performed
Assessment of additional data and/or inputs and identifying the gaps
Preparation of response package with scientific justifications and supporting documents
Correspondence with EMA/other EU countries for extension request and negotiation on the strategy