Insights
REGULATORY PROCEDURES – SOLUTION on eCTD PUBLISHING AND SUMBISSIONS
Under Covid-19 emergency your company can face several challenges due the mandatory lockdown in place, and you may need a support even on a temporary basis to cover the overload or the shortage of publishers available in house.
RPN electronic publishing team assure on-time submission that meets all EMA / US FDA regulatory requirements with more than 15 years of experience gained in the eCTD submissions.
RPN eCTD submission support includes the following services for EU CTD, ASMF, IMPDs, IND, NDA, ANDA, DMF, etc.:
- eCTD-ready templates for authoring submission content
- Document level services, including document formatting and PDF generation, bookmarking and hyperlinking documents
- eCTD conversion of paper applications
- eCTD compilation and publishing
- Submission planning and management
- eCTD building up with full validation performance
- Submission lifecycle management
Regulatory Pharma Net is available to provide full support for any query.
01-04-2020
