Regulatory Publishing and Submissions - Overview
Global Health Authorities are accepting Regulatory submissions in 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 in on-time Regulatory Publishing and Submission services for all acceptable formats such as paper, electronic submissions, eCTD, and NeeS.
Freyr assists Life Sciences organizations in streamlining the entire Regulatory Publishing and Submissions management process. The Regulatory filing process initiates right from Regulatory dossier development, including 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.
With extensive regional experience in North America (USA and Canada), Europe, LATAM, MEA, ROW, and 260+ submission experts, our team supports organizations with end-to-end delivery in eCTD, NeeS, and Paper Submissions.
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 to 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.
Freyr’s Regulatory Publishing and Submissions
Regulatory Publishing and Submissions
- Comprehensive Regulatory expertise offering a seamless submission support experience, supported by our submission Handyman's Regulatory expertise which consists of a Publishing Manager, Lead Publisher, Senior Publishing Specialist, and Document Specialist
- Experienced global publishing network ensuring submissions with quick TAT
- Leverage last-minute submission requests and ad hoc support
- Tailored support options by choosing dedicated team support for specific project needs
- Onshore/Offshore flexibility: Optimize efficiency with diverse resource options
- Expert project management: Technical oversight ensures smooth operations
- Seamless system migration: Effortless transition between systems
- Well-defined submission processes: Clearly outlined processes for consistency
- Submission tracking and management: Stay organized with comprehensive tracking
- Submission planning expertise: Strategic planning for major submissions and reports
- Compliance with health authority standards: Expertise in meeting Regulatory requirements
- Rigorous QC and review processes: Ensure accuracy and compliance at every stage
- Health authority dispatch services: Secure and timely submission dispatch worldwide
- Archiving solutions: Safeguard submissions for future reference and compliance
- Major applications management: Proficient in handling NDA, BLA, IND, DMF, NDS, ANDS, MAA, CTA, and lifecycle maintenance submissions
- Diverse submission types: Experienced in managing Amendments, Variations, Safety Reports, Annual Reports, and Advertising and Promotional Submissions
- eCTD 4.0 support: Providing comprehensive submission support tailored to the eCTD 4.0 format, ensuring seamless compliance with evolving Regulatory standards
Publishing and Submission
