,Regulatory Publishing and Submissions - Overview
Global Health Authorities are increasingly accepting Regulatory submissions in electronic formats. The need of the hour is to deploy robust and continually updated Regulatory Publishing and Submissions tools to manage region-wise submission documents in compliance with specific formatting requirements. Freyr ensures error-free submissions with the highest quality and has established a strong track record in delivering on-time Regulatory Publishing and Submissions services across all acceptable formats—paper, electronic submissions, eCTD, and NeeS.
Freyr assists Life Sciences organizations in streamlining the entire Regulatory Publishing and Submissions management lifecycle. This begins with Regulatory dossier development and extends through submission management, planning, tracking, publishing, and final submission to Health Authorities (HAs), including confirmation and acknowledgment for Regulatory approvals.
With extensive regional expertise across North America (USA and Canada), Europe, LATAM, MEA, and ROW, and a team of 260+ submission experts, Freyr delivers comprehensive support for eCTD, NeeS, and paper submissions.
In addition to expert-led services, Freyr provides access to its industry-recognized eCTD publishing and electronic submission software, Freya.Submit. This solution empowers companies to meet diverse and evolving Regulatory Publishing and Submissions requirements efficiently, enabling faster reviews and quicker approvals for products including drugs, biologics, and medical devices.
Apart from deploying experienced experts to provide Regulatory Publishing and Submission services, Freyr offers industry-proven eCTD publishing and electronic submission software, Freya.Submit. This advanced tool enables life sciences companies to meet diverse and evolving global requirements efficiently—supporting quicker review cycles and faster product approvals for drugs, biologics, and medical devices.
Freyr’s Regulatory Publishing and Submissions
Regulatory Publishing and Submissions
- Comprehensive Regulatory expertise offering a seamless submission support experience, backed by our dedicated team consisting of a Publishing Manager, Lead Publisher, Senior Publishing Specialist, and Document Specialist
- Experienced global publishing network ensuring submissions with quick turnaround times
- Responsive to last-minute submission requests and ad hoc support
- Tailored service models, including dedicated team support for specific project requirements
- Onshore/offshore resource flexibility to optimize cost and efficiency
- Expert project management and technical oversight for seamless operations
- Hassle-free system migration support
- Clearly defined and repeatable submission processes
- End-to-end submission tracking and management
- Strategic submission planning for major reports and applications
- Full compliance with Health Authority standards
- Rigorous quality checks and review processes at every stage
- Secure and timely dispatch services to global Health Authorities
- Reliable archiving solutions to ensure traceability and future compliance
- Full-spectrum application management: NDA, BLA, IND, DMF, NDS, ANDS, MAA, CTA, and lifecycle maintenance submissions
- Expertise in diverse submission types: Amendments, Variations, Safety Reports, Annual Reports, and Advertising/Promotional Submissions
- Advanced eCTD 4.0 capabilities: Ensuring seamless compliance with the latest Regulatory requirements
Publishing and Submission
