Incorporating Software in Combination with Medical Devices Hardware
Published Dec 04, 2023
Published 12th October 2023
Feeling overwhelmed by the prospect of preparing and submitting an eCTD application? DLRC Regulatory Operations is here to provide you with a comprehensive solution that ensures your submission is not only timely but also fully compliant with global regulatory agencies.
No matter where you currently stand in your regulatory journey, our dedicated DLRC Regulatory Operations team is ready to assist and support you in achieving your submission goals.
Our global team is a diverse blend of experts with backgrounds in pharmaceuticals, clinical research organizations (CROs), and regulatory consultancy, boasting an impressive collective experience of over 70 years in publishing and submission management. We’ve successfully guided numerous applications, including CTA, IND, NDA, MAA, and IMPD, from the initial pre-submission stages all the way to post-approval.
Our extensive technical expertise and meticulous submission management processes serve as the bedrock for surpassing your submission milestones. We pride ourselves on delivering submission-ready standard (SRS) documents, comprehensive content plans, and published eCTD structures that adhere to the highest validation standards for various types of applications.
How do we achieve this? At DLRC, we work closely with all stakeholders involved, providing guidance and direction on every aspect of the submission process. This includes strategic submission planning, document templates, submission content plans, modular eCTD structures, lifecycle management, document placement, regional requirements, quality control reviews, and gateway access.
At DLRC, we also leverage state-of-the-art tools and systems to manage documents, including Veeva Vault systems, proficient submission build software, and secure access to major regulatory authority portals.
One real-world example of our success is our collaboration on a project, where we began working together a year prior to the planned submission date. Our dedicated Regulatory Operations leads actively participated in project meetings right from the beginning, offering valuable insights into FDA document submission standards, dual key milestone deliverables, and a robust review process. Like many projects, we faced challenges, including delays in the delivery of critical clinical data that impacted Module 2. Despite these obstacles, our client-centric approach and unwavering determination allowed us to submit the NDA on schedule, meeting the deadline by a day.
If you’re ready to start your submissions journey with a partner you can trust, don’t hesitate to reach out to the Regulatory Operations Team at DLRC by emailing the team at firstname.lastname@example.org, or using the link below.
No matter where you find yourself on your regulatory path, make DLRC your preferred partner for knowledgeable, efficient, professional, and friendly support. Your success is our priority.