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, 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.