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Global Expert Data Submission Support for FDA and EMA
Successfully navigate complex submission pathways with our tailored support for FDA, EMA, and global regulatory data requirements.
Navigate the Submission Landscape with Confidence
Our specialized support will help you navigate the challenges of regulatory submission, to ensure your data is submission-ready — 100% of our data sets achieve regulatory acceptance. We understand that submissions are the pivotal culmination of your clinical trials, demanding precision and strategic foresight. They are intricate processes that involve a detailed presentation of clinical study data for regulatory review. We have extensive experience in pre-NDA reports, integrated summaries, and CDISC standards, and our industry-leading team ensures submissions are comprehensive, coherent, and compliant, building a foundation for successful drug approval.
Contact usRegulatory prowess
Decades of successful FDA and global submissions, honed by continuous regulatory dialogue for flawless data presentation and review, including strong expertise in the Therapeutic Area User Guides.
CDISC expertise
Mastery in ADaM and SDTM models, ensuring impeccable data structure, standardization, and traceability for regulatory bodies.
Strategic ISS/ISE planning
In-depth planning from inception, including gap analysis, to give you coherent and comprehensive integrated summaries for submission.
Future-ready submissions
Staying ahead with evolving open-source initiatives and regulatory standards, we ensure your data meets the latest submission requirements.
Tailored Submission Report Services
Work with us to refine your pathway to drug approval, choosing from our suite of submission services including pre-NDA submission reports, integrated analysis plan writing, and summaries of safety & efficacy. Our expertise includes CDISC migration and eCTD report writing, offering an all-encompassing package for regulatory submissions. Each service is crafted to align with regulatory expectations, ensuring your submission is robust, comprehensive, and positioned for success.
Expert CDISC Implementation
Embracing the CDISC standard is critical for submission success. We have deep expertise in ADaM and SDTM, providing a solid framework for data consistency and traceability. Our team ensures each of your datasets tells a clear story from collection to analysis, meeting the FDA’s stringent traceability requirements and securing a smooth regulatory review process.
Strategic ISS/ISE Integration Support
Successful NDA submissions require Integrated Summaries of Safety (ISS) and Efficacy (ISE). Cytel excels in planning and preparing these summaries, starting with a thorough gap analysis to identify data inconsistencies and guide seamless integration. Our support enables your biostatisticians to construct comprehensive, accurate ISS/ISE reports that consolidate safety and efficacy data across studies, enhancing the credibility of your findings and instilling confidence in regulatory reviewers.
Pioneering Future Submission Standards
We anticipate the future of regulatory submissions to remain at the forefront of new standards development and regulatory requirements. Our focus on the latest updates, including open-source initiatives and evolving technical specifications, positions your data to meet tomorrow’s standards today, ensuring ongoing compliance and submission excellence.
Data Submission eBook
Interested in learning more about data submission? Download our complimentary ebook, The Good Data Doctor on Data Submission and Data Integration
Download eBook
100%
Regulatory acceptance of our data sets
10
Annual regulatory data submissions
>50
Cytel presentations on CDISC
5
Annual FDA BIMO (Bioresearch Monitoring)
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