eCTD Submission Services & Software Solutions FDA, EMA
- Freyr Global Regulatory Solutions
- May 18, 2018
- 1 min read
We offer eCTD Submission & Publishing services to Life Sciences Industry for approval of Drugs/Medicines, Converting Non-eCTD format/Paper to eCTD format to comply with FDA, EMA, Health Canada, Swissmedic, SFDA, MOH, MCCZA, Thai FDA, TGA
With a comprehensive knowledge of global Regulatory publishing trends and submission formats (for example eCTD/Non-eCTD electronic submissions [NeeS]), Freyr supports dossier submissions across the globe. For efficient, effective and multi-country filings, Freyr offers data compilation, data publishing and dossier dispatches through an in-house Regulatory publishing and submission software, Freyr SUBMIT, that supports global HA submission formats. Adhering to the United States Food and Drug Administration (USFDA), ICH HL7 standards, Freyr is a strategic partner for multiple submissions within brief timelines, which has proven to be very cost-effective for organizations.
Freyr as an end-to-end eCTD Regulatory software provider assists organizations with Freyr SUBMIT to effectively handle all the Regulatory submissions requirements, that is, handling end-to-end document life cycle and region-specific eCTD templates/formats.
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