eCTD Services – Regulatory Submission Outsourcing
The electronic Common Technical Document (eCTD) submission process is often a significant, costly barrier in the product development lifecycle. It is required by FDA for INDs, NDAs, DMFs, along with other filings. Pearl Pathways’ eCTD Services are equipped to support all of your regulatory publishing project needs.
A dedicated submission expert will be assigned to each of your projects, acting as your single point of contact and lead coordinator of the project with Pearl Pathways’ internal regulatory and publishing team.
Attention to detail and client satisfaction are the key metrics that we strive to achieve through our eCTD submission process.
Our comprehensive eCTD services include:
- Project management of all regulatory submissions
- Formatting and editing of regulatory documentation
- Preparation of documents and references for submission
- Verification and insertion of appropriate document hyperlinks
- Initial submission of IND, NDA, ANDA, BLA, & Drug MasterFile (eDMF) submission and maintenance
- eCopy for medical device submissions
- Preparation and publishing of amendments and supplements
- Country-specific composition, publishing, and validation for submissions in the US, EU, and Japan
- Utilization of our cloud based software portal to ensure accurate and timely submissions
- Secure transfer of submission through our company FDA gateway
- Document authoring and medical writing services
- Storage and archival of the eCTD file on our secure 21 CFR Part 11 compliant server
Pearl Pathways will provide you with initial filing, ongoing publishing, and maintenance support for all of your eCTD filings.
Outsourcing e-submission projects to Pearl Pathways allows our clients to focus resources on their products and reduce additional overhead costs. We find that this model provides a competitive advantage over “purchasing a seat” on an eCTD software package for in-house use because it allows our clients to allocate more time towards core competencies and revenue generating activities.