eCTDmanager - Seamlessly oversee, publish, and validate regulatory submissions.
Effectively handle, publish, and validate multi-region eSubmissions and product dossiers.
How many tools are necessary for submission management?
Navigating the complexities and time demands of publishing and maintaining regulatory submissions compliant with diverse regional standards can be challenging.
Achieving global regulatory compliance effortlessly.
Streamlined dossier assembly:
Utilize a comprehensive regulatory dossier assembly environment for handling electronic submissions, even without prior XML technology knowledge.Support for various standards:
Construct, review, validate, and publish compliant submissions based on a range of standards including eCTD, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications, and other regional formats.Automated technical validation:
Benefit from built-in technical validation to ensure submission validity according to the latest criteria provided by global regulatory authorities.Efficient lifecycle management:
Efficiently track all modifications and updates to your submissions.
We Provide Best Digital Services to Grow your Business
- COMPLY WITH REGULATORY REQUIREMENTS WORLDWIDE
- CUT DOWN ON REVIEW, APPROVAL AND DELIVERY TIMES TO MARKET FOR ALL OF YOUR PRODUCTS
- USE ADVANCED AUTOMATION TO REDUCE ERRORS AND INCREASE PRODUCTIVITY
Submission Management software tools are designed to meet the needs of both the pharmaceutical and crop industry. They cover all global standards like eCTD or NeeS. We provide safe and compliant submission and lifecycle management software, which is essential for your business success in the fast-changing and highly regulated environment of these industries. All hubs provide you the greatest flexibility in designing your IT infrastructure on-premise or cloud-based.
More than 35 regulatory authorities work with us to ensure eCTD and NEES compliance. Ensure compliance with regulatory requirements worldwide. Reduce errors and increase productivity through advanced automation.
Discover our company's essence. With a blend of experience and innovation, we're committed to delivering top-tier solutions. Unveil our journey, values, and expertise, and join us in shaping excellence.
