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

Regulatory standards and processes around the world are changing frequently – eCTD 4.0 is the next step.

Submission requirements are constantly evolving, with updates and revisions being issued regularly by regulatory bodies. This means that you need to stay up-to-date with the latest changes to ensure that you remain compliant with regulations. Failure to do so can result in costly delays or even the rejection of a submission.

To learn how to stay compliant, download our whitepaper outlining the changes that eCTD 4.0 brings. It highlights the impact on life science organisations and provides guidance on how to comply with the new requirements.

Step 1: Download the Whitepaper.

Step 2: Learn about the impact of eCTD 4.0.

Step 3: Ensure your submissions remain compliant.

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Download the free Whitepaper

Our Customers

cinfa
ABDiiBRAHiM
Merck
BBRAUN
SANOFI
We have worked with over 1000 customers and 35 regional authorities using our technology and expertise to create, review and publish electronic and paper submissions.
“eCTDmanager was by far the most user-friendly, most functional, intuitive, and cost-effective solution we found on the market.”
Lian Qingling, responsible for international registrations at Qilu Antibiotics (Linyi) Pharmaceutical Co.