Agency Interactions

Engaging with regulatory agencies early can significantly impact your development strategy. Our team will facilitate meetings to discuss your development plans, identify potential regulatory challenges, and gather preliminary feedback from the agencies. Additionally, obtaining scientific advice from regulatory authorities (for instance Innovation Task Force (ITF) meetings, Scientific meetings (EMA) or Formal meetings (FDA)) ensures that your development program aligns with regulatory expectations. We prepare detailed briefing documents, manage meeting logistics, and provide strategic recommendations based on our expertise and the advice received, ensuring that your scientific and regulatory strategies are on track.

Prior to submitting your Investigational Medicinal Product Dossier (IMPD) or Investigational New Drug (IND), we organize pre-IMPD/IND meetings to discuss your quality/CMC and preclinical data, proposed clinical trial design, and overall development plan. This early interaction helps mitigate risks and streamline the IMPD/IND submission process. Furthermore, end-of-phase meetings with the EMA, FDA or other regulatory authorities at the end of each phase of clinical development provide an opportunity to review progress and address any regulatory concerns before moving to the next phase. We assist in preparing comprehensive documentation and in representing your interests during these interactions.

As you approach the final stages of your development program, we arrange pre-MAA (Marketing Authorization Application) or pre-BLA/NDA meetings to discuss the format and content of your upcoming submission. Our experts ensure that all regulatory requirements are met and that your submission strategy is robust. Our team provides end-to-end support for the preparation and submission of your MAA/BLA/NDA. We meticulously compile and review all necessary documentation, ensuring compliance with regulatory standards. Our submission management services include eCTD formatting, publishing, and submission to the relevant regulatory authorities.

After submission, we manage interactions with regulatory agencies, including responding to queries, providing additional data, and managing advisory committee meetings. Our proactive approach ensures timely and accurate responses, facilitating a smooth review process. Upon receiving marketing authorization, we will continue to support you with post-market surveillance, regulatory reporting, and lifecycle management. Our experts stay abreast of regulatory changes and provide ongoing advice to ensure continued compliance and market success.