Are you preparing to address the Day 120 List of Questions (D120 LoQ) from the Spanish Agency of Medicines and Medical Devices (AEMPS), following the submission of your MAA for Group I allergen products in Spain under the new regulatory framework?
At Asphalion, we can support you in the preparation of robust, well-structured, and scientifically sound responses, including:
- Non-clinical and clinical safety and efficacy justifications, based on bibliographic and/or proprietary data
- Module 1 objections, including those related to the SmPC, ERA, RMP, and other regulatory documentation
- Regulatory support in defining the response strategy, including the assessment and justification of the most appropriate legal basis for the dossier
- Support in the preparation and review of regulatory documents, as well as in the overall adaptation of the dossier to ensure consistency of the response
- Assistance in the planning, preparation, and management of readability user testing, when required
- Additional key elements required to adequately support your dossier and facilitate the response process
We have broad experience in supporting responses to agency questions and preparing solid scientific and regulatory justifications.
Feel free to contact us to discuss your needs: [email protected]
