Gap Analysis and Authoring - Overview
Whether an application is required for a new generic product application, or post-approval life-cycle maintenance, conducting thorough MAA submissions gap analysis and accurate authoring can be crucial when preparing any application. They help to minimize avoidable delays, and reduce the risks of rejection, and are thus important in leading to health authority approvals. A gap analysis review of submission documentation against the relevant European guidelines and Regulatory standards plays a significant role in identifying potential deficiencies in documentation submission and can also be important in determining issues for discussion at pre-submission meetings. Such reviews also help identify any risk areas and facilitate the preparation of a risk mitigation plan.
Following the completion of an MAA submission gap analysis exercise, the results must be reviewed in detail and a plan developed to address any issues identified. The plan may include generic medicine authoring to create new documents or amendment of existing documents to address issues with existing ones.
Freyr is an expert in Regulatory submissions, and, with a highly skilled cross-functional team, it assists applicants in determining the applicable HA requirements and can perform comprehensive, sequential gap analysis and document authoring for all phases of the Regulatory process.
Gap Analysis and Authoring - Expertise
- Regulatory assessment and gap analysis of source documents/data for suitability in line with European health authority requirements
- Identification of gaps and necessary mitigation strategies
- Knowledgeable resources with previous experience in R&D, Quality and Analytical departments to help with in-depth reviews
- Review of documents, data and reports to assess compliance with HA expectations
- Implementation of best practices based on previous experience of MAA submissions gap analysis and authoring
- Experienced resources with the skills to interpret European health authority guidance and requirements
- Authoring CTD sections using CTD templates aligned with European health authority requirements for content and format
- Authoring of other documentation in line with relevant guidelines to support post-approval submissions
