This week at Asphalion, we’re highlighting key regulatory topics as part of our Regulatory Operations eSub-Week series. Today, the spotlight is on global eCTD implementation.
Since the introduction of eCTD, Asphalion has been at the forefront of electronic submission of regulatory information. Thanks to our flexible support and dedicated project management, we deliver high-quality submissions within critical timelines across all regions.
To help you navigate the international regulatory landscape, we have developed a set of informational flyers on eCTD submissions worldwide, covering the following regions:
- Health Canada
- FDA eSubmission service
- Submissions in Switzerland
- Gulf Cooperation Council regulatory services
- eCTD submissions in Australia
- ASEAN submissions
- Taiwan (TFDA) submissions
- South African (SAHPRA) submissions
At Asphalion, we provide strategic advice, expert consulting, operational support, and full outsourcing services for all types of products in every therapeutic area. Our eSubmission team supports eCTD services across all regions, as well as paper-based and NeeS submissions, guiding you through every step of the regulatory pathway.
Explore these regions in more detail by viewing our brochure, and reach out with any questions: eCTD Global Implementation
Contact us for more information or regulatory support: [email protected]
