In the dynamic and highly regulated pharmaceutical industry, time is often as critical as the quality of the submissions to health authorities. A leading US-based pharmaceutical company recently encountered a substantial challenge: submitting a Supplemental New Drug Application (sNDA) for a cardiovascular drug indication. The core of this challenge lay in the creation and refinement of over 6000 CSR narratives within a tight deadline, a task that required a blend of precision, speed, and regulatory compliance.
The Multifaceted Challenge:
The task at hand involved not just the composition of patient narratives but also maintaining a high standard of quality and compliance with stringent regulatory guidelines. The sheer volume of over 6000 CSR narratives demanded a sophisticated approach to balance efficiency without compromising quality and regulatory adherence.
MMS’ Comprehensive Solution:
MMS Holdings responded with a strategic and innovative approach, employing a Cross-Functional Narrative Development Solution. This solution was designed to harness the strengths of various specialized teams within MMS, ensuring a streamlined and efficient process.
Innovative Automation by the Programming Team:
Our Programming Team took a groundbreaking approach by developing a system to automate the creation of over 6,000 narratives. This system included visual aids for easy tracking of updates, significantly enhancing the efficiency of the reporting process.
Diligent Narrative Writing:
The Narrative Writing Team, working in tandem with the Programming Team, meticulously composed 6,217 narratives from the ground up. Following the integration of the final data, the team updated these narratives, effectively doubling the total count to a staggering 12,434. This approach was pivotal in providing in-depth insights and a comprehensive interpretation of the safety data.
Rigorous Quality Control and Assurance:
The Programming Team implemented a rigorous double-programming strategy for all auto-generated narratives, ensuring unparalleled precision at every developmental stage. Meanwhile, our Quality Control (QC) team undertook a comprehensive review of all 12,000+ narratives, ensuring each met the highest standards of content accuracy, consistency, and regulatory compliance.
Flawless Publishing:
Our Publishing Team meticulously handled the publication of 14,483 narrative pages. Each page underwent rigorous QC checks, including scrutiny of the smallest changes, to ensure compliance and quality.
The Outcome: Exceeding Expectations
The collaborative and innovative efforts of MMS Holdings’ teams led to a significant acceleration of the submission process. The pharmaceutical sponsor was able to advance their sNDA submission deadline by an impressive 2 months. This achievement not only highlighted MMS Holdings’ capability to manage extensive regulatory writing projects but also solidified its reputation as a trusted partner in the CRO industry.
Client Testimonial: A Reflection of Success
The Director of Regulatory Affairs of the pharmaceutical company expressed profound gratitude, stating, “Without your fantastic effort on these submissions, we would not have been able to meet our accelerated timeline. Many thanks for your tireless contributions to this project!” This testimonial underscores the impact and value of MMS Holdings’ commitment to its clients.
The successful completion of this sNDA submission is a testament to MMS Holdings’ unwavering dedication to innovation, quality, and efficiency in the pharmaceutical regulatory environment. This project exemplifies how MMS Holdings effectively combines technological prowess with expert knowledge to set new benchmarks in the industry, constantly striving to exceed client expectations. If you’re facing similar regulatory challenges or need expert guidance in navigating the complexities of drug development and submission, MMS Holdings is here to help. To explore how we can support your specific needs and align your strategies effectively, please click here to start a conversation with our experts today. Our team is ready to bring their expertise to your unique situation, ensuring your project’s success with the same commitment and precision demonstrated in this sNDA submission.
Authored by: Senior Director, Safety Risk Management, Drug Safety and Pharmacovigilance