Submitting the best possible dossier to global regulatory authorities requires a multifaceted approach of careful upfront planning, in-depth analysis, efficient filing and responsive post-submission support. At Quintiles, we bring together cross-disciplinary perspectives early in the planning process to identify gaps and design corrective actions to keep your timelines on track.
To get more insight into the process, we reached out to some Quintiles regulatory, medical writing and biostatistics professionals, to share some basic tips for producing high quality regulatory dossiers.
- A big first step in ensuring quality and understanding your probability of approval will be to discuss development plans upfront with regulatory agencies
- Assign a dedicated, cross-functional, experienced team to write the dossier
- Complete an in-depth gap analysis of available data by functional experts against the expected requirements and guidelines in the region
- Prior to drafting results, create outlines that are comprehensive, clear, complete and thoroughly reviewed and approved by all stakeholders
- Allow sufficient time for 360 degree review by medical, biostatistical, regulatory, and quality control at appropriate time-points while preparing documents
- Develop and implement a robust, fully QCed, validated, and documented process for all sections of the dossier
- Have an independent team of senior reviewers to review the CMC, non-clinical, statistical, clinical, and administrative deliverables of the team
- Integrate lessons-learned from past or ongoing projects on the expected quality and extent of data foreseen by the targeted Regulatory Agency
- Clearly communicate to all stakeholders how documents will be reviewed and how changes will be received and incorporated.
- It is essential to perform a format QC of every document that you include in a dossier. This includes ensuring the documents meet electronic common technical document (eCTD) guidance, that all hyperlinks and bookmarks are correct, and that the document is formatted correctly. In addition, the most critical aspect of the eCTD is to perform a complete validation prior to submittal, which will ensure it passes regulatory agency technical validation.
To learn more about our approach regulatory submissions download the factsheet or email us.
Special thanks to our contributors: Terry Weber Sosa, Executive Director of Biostatistics at Quintiles, Kristina Brannstrom, Director of Medical Writing at Quintiles, Laurie Henricks, Senior Director of Regulatory Affairs, and Valerie Codrons, Manager of Regulatory Affairs