Gap Analysis and Authoring - Overview
Thorough Regulatory assessment/gap analysis of the source documents/data and the first-time-right quality authoring of CTD sections for an ANDA application are very vital to clear the RTR screening and also receive the approval in the first review cycle on the goal date, which allows the manufacturer/ANDA holder to market the generic drug in the USA region without delay.
Gap analysis of all source documents/data/study reports helps in identifying the gaps in the ANDA content and can allow to building of the mitigation plan and strategy to provide logical and scientific justifications to avoid major queries from the USFDA subsequently to receive approval on time.
Freyr, with a highly skilled cross-functional team and expertise in Regulatory submissions, can assist applicants in determining the HA requirements and perform comprehensive ANDA gap analysis and authoring of source documents/data.
Gap Analysis and Authoring - Expertise
- Regulatory Assessment/Gap analysis of the source documents/data for adequacy as per the USFDA requirements
- Sharing of identified gaps Providing the necessary mitigation strategy for identified gaps
- Experienced resources with previous experience in R&D, quality and analytical departments for an in-depth review of the documents/data
- Review of the documents/data/reports for their compliance with Refuse-To-Receive (RTR) standards
- Implementation of best practices/guidance/queries with previous submission to the USFDA in ANDA gap analysis and authoring
- Authoring of CTD sections using the CTD templates as per the USFDA’s ANDA requirements for content and format
- Authoring of CTD sections for supplements/amendments/annual reports to the registered applications as per the USFDA expectations
- Assessment of the Regulatory submission strategy
- Review of the qualitative and quantitative composition of the medicinal product for acceptability
- Impurities limits as per the ICH requirements based on MDD
- Gap analysis of the protocols/reports for product development, process validation, stability program, exhibit batches, batch size for registration, hold time study
- Dissolution method/parameters selection
- Biowaiver criteria
- Health Authority mandatory requirements
- Gap analysis of draft CTD package to ensure the adequacy for submissions like ANDAs/DMFs
- Gap analysis of the supplement submission strategy and suggestions
