Paper Regulatory Submissions

Freyr's expert team streamlines paper Regulatory submissions and offers comprehensive paper-to-eCTD conversions, ensuring efficiency and compliance with Health Authorities that accept electronic formats, minimizing additional efforts and costs for companies.

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Paper Regulatory Submissions - Overview

Although the electronic common technical document (eCTD) has been set as a standard format by a majority of Health Authorities (HAs), a paper copy of the dossier is still a legal requirement for the rest. Earlier, Regulatory submissions in paper format were produced aligning with the paper-based common technical document (CTD) format. That necessitated the production of two (02) different submissions if an eCTD or non-eCTD electronic Submissions (NeeS) were to be submitted. With two (02) different sets of submission formats, the execution and implementation demanded considerable additional efforts, affecting the company’s costs. The only pragmatic solution to overcome this complexity was to allow applicants to use the eCTD or NeeS as the antecedent submission, after which the official Regulatory submissions in paper format are printed. The printed copy primarily comprises a verified paper dossier submission format. However, it is important to note that the Regulatory Submissions in paper format is not intended to support dossier review as it has no paper-based navigation and review aids (for example, tables of content that reference paper volumes, tabs, etc.).

Freyr, with an expert paper Regulatory submissions team, caters value-added assistance for dossier submissions in the paper and eCTD formats. With a strong foothold in the global Regulatory regime, Freyr decodes region-specific paper-based technicalities and Regulatory submissions in paper formats to streamline paper Regulatory submissions and offers comprehensive paper-to-eCTD conversions to support submissions to the HAs that accept the electronic format.

Paper Regulatory Submissions

  • Navigation and management of volumes with separators or tabs.
  • Dispatching and delivering paper submission of Regulatory Information as per the HA specifications for paper publishing.
  • Paper to eCTD conversion/transition.
  • Baseline Paper submission of Regulatory Information.
  • Proven expertise in dispatching large volumes of Regulatory submissions in paper format.
  • Well-versed Regulatory team keeping track of the ever-changing Regulatory guidelines.
  • Point of contact for each paper submission of Regulatory Information.
  • Dedicated QC teams.
  • Quick submission turnaround times (includes single-day submissions).

Seamlessly Navigate the Paper Submission Process

Partnering with Leading Organizations

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​