eCTD Publishing & Submission Services
Regulatory filings in electronic CTD have become the mandatory or preferred method for many regulatory agencies. AXSource Consulting offers regulatory submission compilation and filing in the electronic Comment Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS) formats. Our regulatory experts will prepare, publish, validate, and review your submissions for more cost-effective filings. With the added benefit of having our on-site IT company and our own ASA (AXSource Secure Architecture), AXSource is more than ready to support all your eCTD outsourcing needs.
XML PM & SPL Labeling
AXSource offers professional services in Structured Product Labeling (SPL) for Health Canada and the United States FDA.
There are enormous benefits to outsourcing
your eCTD Services
AXSource Secure Architecture (ASA)
Reduce the impact on internal resources
Eliminate cost for an expensive in-house system
Expedite regulatory review by using our experienced publishers
Validation of your eCTD submission(s)
Reduce administrative & maintenance burden
Electronic Submission Types
| Electronic CTD(eCTD) Services |
|
Query management to support clients. Complete validation and acknowledgement. Where necessary, supplementary support for paper, documentation, compact disk and/or USB devices is accommodated. Health Canada electronic CTD: NDS, SNDS, ANDS and SANDS; Non-electronic CTD electronic-only: Medical Device and Veterinary Drug regulatory activities.
FDA eCTD: NDA, BLA, ANDA, CTA, DMF and IND. |
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| NeeS | Supporting clients with preparation & review of Non-eCTD electronic submissions. |
| Device, NHP & Cosmetic e-Filings | Medical Device submission (FDA eSubmitter), NNHPD submissions (Trading Partner) and Cosmetics registrations are supported. |
Maximize Efficiency and Accuracy in Regulatory Submissions – Partner with AXSource Consulting Now!
FAQs for eCTD Publishing Services
What is eCTD publishing and why is it important for regulatory submissions?
eCTD (Electronic Common Technical Document) publishing is the process of compiling and submitting regulatory information electronically in a standardized format. It is crucial because it streamlines the submission process, enhances data integrity, and facilitates easier review and approval by regulatory agencies.
How can pharmaceutical companies streamline their eCTD submissions?
Companies can streamline their eCTD submissions by using specialized software tools, maintaining consistent document formatting, ensuring accurate metadata, and conducting thorough quality checks before submission.
What are the best practices for eCTD publishing?
Best practices include adhering to regulatory guidelines, using validated eCTD software, maintaining version control, ensuring proper document granularity, and conducting regular training for staff involved in the submission process.
What eCTD publishing software tools are recommended for eCTD submissions?
Recommended software tools for eCTD submissions include Lorenz docuBridge, Extedo eCTDmanager, and MasterControl. These tools help in compiling, validating, and submitting eCTD documents efficiently.
How does the eCTD format improve the review process for regulatory agencies?
The eCTD format improves the review process by providing a standardized structure, which makes it easier for regulatory agencies to navigate and review submissions. It also allows for quicker access to specific sections and reduces the risk of errors.
What are the common challenges faced during eCTD publishing?
Common challenges include managing large volumes of data, ensuring compliance with varying regional requirements, maintaining document consistency, and dealing with technical issues related to eCTD software.
How can metadata enhance the efficiency of eCTD submissions?
Metadata enhances efficiency by providing detailed information about each document, such as its content, version, and submission history. This helps in quick retrieval and accurate tracking of documents throughout the submission process.
What steps should be taken to ensure compliance with eCTD specifications?
To ensure compliance, companies should stay updated with regulatory guidelines, use validated eCTD software, conduct regular audits, and implement a robust quality management system.
How can consistency in eCTD submissions be maintained?
Consistency can be maintained by using standardized templates, conducting regular training for staff, implementing strict version control, and performing thorough quality checks before submission.
What are the key components of a successful eCTD submission plan?
Key components include a clear project timeline, defined roles and responsibilities, comprehensive training for staff, use of validated eCTD software, and a robust quality assurance process.
