Freyr assists Life Sciences organizations to streamline the entire Regulatory Publishing and Submissions management process. The Regulatory Filing process initiates right from dossier development that includes Regulatory Submission Management and Regulatory Submission planning, tracking, Regulatory publishing, and making the final regulatory submissions to Health Authorities (HAs) including delivery confirmation/acknowledgment for their Regulatory approvals.

As global HAs are accepting Regulatory submissions in the electronic format, the need of the hour is to deploy robust and ever-updated Regulatory publishing and submission tools to manage region-wise Regulatory submission Documents and region-specific formats. Freyr ensures error-free Regulatory submissions with the utmost quality and has proven itself for on-time Regulatory publishing and submission services for all kinds of acceptable formats such as paper, electronic submissions, eCTD, and NeeS.

Apart from deploying experienced experts to provide Regulatory publishing and submission services, Freyr offers industry-proven eCTD publishing and electronic submission software, Freyr SUBMIT PRO, to enable companies effectively meet all their specific and unique Regulatory publishing and submission services requirements for quick reviews and faster approvals of their products such as drugs, biologics, and medical devices from the Regulatory Authorities.

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  • Comparison of Regulatory Submissions for eCTD in USA & China
    Publishing & Submissions

    Comparison of Regulatory Submissions for eCTD in USA & China