An emerging pharmaceutical company with a primary focus on developing a breakthrough agent for pulmonary sarcoidosis. To navigate the complex regulatory landscape and ensure successful development, they sought strategic and tactical regulatory support from Lumanity.
The client required comprehensive regulatory support in critical phases of their investigation drug’s development. These phases encompassed activities like Regulatory Strategy, Medical Writing, and eCTD Publishing Support.
- Phase 1: Pre-IND Meeting, IND Preparation for Sarcoidosis: In this phase, Lumanity diligently worked on developing and submitting the pre-IND meeting package for Sarcoidosis, as well as preparing responses to FDA WRO (Written Request for Information). The following key activities were carried out:
- Medical Writing of the Clinical Protocol: Lumanity provided expertise in crafting a well-defined and scientifically sound clinical protocol.
- Medical Writing of Clinical Summaries: Lumanity demonstrated its expertise in meticulously crafting well-defined and scientifically sound clinical summaries. These summaries served as critical documents summarizing the essential findings and outcomes of the clinical trials, and providing comprehensive insights for regulatory submissions.
- eCTD Publishing Support: Lumanity assisted the client in preparing and publishing electronic Common Technical Document (eCTD) submissions. This ensured the regulatory dossier was in the required format for streamlined submission to regulatory agencies.
Through the dedicated regulatory guidance and publication support provided by Lumanity, our client achieved a positive outcome from the FDA. The regulatory authority issued a letter granting permission to proceed with the proposed clinical investigation, reflecting the effectiveness of Lumanity’s support.
Lumanity’s strategic and tactical regulatory support played a vital role in helping the emerging pharmaceutical company navigate the regulatory challenges in developing their agent for pulmonary sarcoidosis. The successful outcome from the FDA not only boosts the client’s confidence in the development process but also underscores Lumanity’s expertise and commitment to advancing innovative therapies through effective regulatory compliance and support.