Successful interactions with health authorities is a key factor in achieving drug product approvals and can have a positive impact on approval timelines and overall costs. In the European region, this can include interactions with the European Medicines Agency (EMA) and European national health authorities (for both EU and non-EU countries).
Contact with health authorities (whether in writing, via teleconference or face-to-face) must be conducted efficiently and effectively whenever it occurs throughout the Regulatory process and lifecycle of a product. Health Authority Interactions such as pre-submission meetings and scientific advice meetings require careful planning to ensure they are requested at the most appropriate time, and that they address all points that enable applicants to progress with their submissions.
Understanding Health Authority expectations and identifying potential risks and weaknesses with Regulatory submission strategies is essential when planning to contact authorities and preparing for appropriate risk-mitigation strategies can help minimise potential delays in Regulatory approval.
Freyr’s team is experienced in planning for Health Authority interactions/meetings and preparing the documentation required to make them successful. Our thorough evaluation of the outcome of such meetings helps ensure that the Regulatory strategies are amended in line with health authority recommendations. Knowledge of different dosage forms, types of Regulatory submission and proven track record in providing Regulatory support have made Freyr become a preferred Regulatory partner to companies across the globe in supporting initial submissions and post-approval maintenance changes.
Regulatory support for all types of medicinal product licences (e.g., National, MRP, DCP, Centralized)
HA query evaluation (including review of the Regulatory submission to which the query relates)
Support in preparation and execution of HA query response strategies
Preparation of HA response documents, including relevant scientific justifications
Assessment of submission documentation, including initial applications and post-approval submissions (e.g., initial validation comments, response to the completeness assessment report, response to the Information Requests (IRs))
Assessment of post-approval submissions (e.g., variations of Types IA, IA, IB and Type II, line extension applications, etc.)
Country specific administrative data (Module 1) requirements
Support in case of application rejection by Regulatory authorities
Requesting scientific advice from the Regulatory authority before/during submission
Coordination and preparation for HA scientific advice meetings
Pre-submission communications (e.g., related to formulation, regulatory strategy, etc.)