Design

Streamline Your Regulatory Pathway with Expert Regulatory Operation Services
https://www.willingjet.com/ectd-publishing-services/


Navigating regulatory operations can be complex, but you don't have to do it alone. At Willingjet, we provide comprehensive regulatory operation services to ensure your submissions are efficient, compliant, and successful. We tailor our solutions for pharmaceutical, biologic, and medical device applications across global markets.

ECTD Publishing Services
Submission Compilation and Publishing
Submitting drug, biologic, and medical device documents can be daunting. Our experts compile and publish your submission dossiers, ensuring they are correctly formatted and meet regional regulatory requirements. We handle everything from planning to submission delivery to health authorities.

Product lifecycle Management
Keeping your product compliant throughout its lifecycle is crucial. We update, amend, and renew your dossiers to stay current and compliant. Our proactive approach helps you address regulatory changes efficiently.

Regulatory Strategy and Consulting
We use our industry knowledge to develop strategies that simplify the regulatory process. Our consulting services help you understand regulatory pathways, identify potential issues, and optimize your approach for quicker approvals.

Global Submission Capabilities
Expand your reach globally with our submission services. We manage all submission formats, including eCTD, across regions like the U.S. (FDA), E.U. (EMA), Japan (PMDA), and China (NMPA). We support all your global regulatory activities.

Compliance and Quality Assurance
Our quality control processes ensure your submissions are error-free and meet all guidelines. We minimize rejection risks by making sure your dossiers comply with current regulations.

Regulatory Process Optimization and enhancement
We help you streamline your dossier execution process, transition to eCTD, and set up data visualization solutions for regulatory operations in emerging markets.