Regulatory Publishing and Submissions

Transform compliance barriers into springboards for exponential growth ensuring seamless submissions and crafting market expansion strategies. With Freyr’s submission experts, streamline the approval processes, adhere to Regulatory guidelines, and increase the likelihood of successful product approval.

  • 300

    +

    Experts
  • 15

    +

    Average years of experience
  • 200

    +

    Global customers/Clients
  • 600

    +

    Projects
  • 200000

    +

    Total Submissions
  • 1000

    +

    Original Submission: (IND, NDA, BLA, ANDA, DMF, NDS, ANDS,  MAA, CTA) 

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 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

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

Success Stories

Freyr Provided Comprehensive Regulatory Support Accelerating Global Submissions and Ensuring Compliance for a Japanese Pharmaceutical and Biotechnology Company Across Multiple Markets
Publishing and Submission

Freyr Provided Comprehensive Regulatory Support Accelerating Global Submissions and Ensuring Compliance for a Japanese Pharmaceutical and Biotechnology Company Across Multiple Markets

The client, a Japanese pharmaceutical and biotechnology company, had sought to accelerate global submissions and ensure compliance. Leveraging a decade-long partnership, they had turned to Freyr for comprehensive support. Freyr provided submission planning, eCTD publishing, and submission services while expanding global resources across multiple countries. This support resulted in faster market entry and improved operational efficiency.

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Freyr Streamlined and Standardized Submission Processes for a Japanese Drug Manufacturer's Successful Market Entry into the US Market
Publishing and Submission

Freyr Streamlined and Standardized Submission Processes for a Japanese Drug Manufacturer's Successful Market Entry into the US Market

The client, a Japanese drug manufacturer, had faced challenges entering the US market and needed to streamline and standardize their submission processes. They had turned to Freyr, who standardized procedures and facilitated a seamless transition from the existing vendor. Freyr's expertise resulted in faster approval cycles, strict compliance with US regulations, and enhanced operational efficiency, enabling the company to successfully enter the US market.

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Freyr Provided Strategic Regulatory Partnership Achieving 100% On-Time Submissions and 50% Cost Savings with a Scalable Hybrid Staffing Model for a Japanese Midsize Global Pharma and Biotech Company
Publishing and Submission

Freyr Provided Strategic Regulatory Partnership Achieving 100% On-Time Submissions and 50% Cost Savings with a Scalable Hybrid Staffing Model for a Japanese Midsize Global Pharma and Biotech Company

A Japanese midsize global pharma and biotech company, having collaborated with Freyr for over three years, had sought Freyr's expertise for comprehensive submission publishing support in the US and Canada. Freyr had defined, implemented, and maintained best practices in publishing processes, ensuring 100% on-time submissions and achieving over 50% cost savings. This significantly boosted the company's process efficiency and compliance.

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Freyr Ensured eCTD Compliance for a US-Based Multinational Company in the EAEU Region Through Expert Consultation and Transition Support from Paper to Electronic Submission Format
Publishing and Submission

Freyr Ensured eCTD Compliance for a US-Based Multinational Company in the EAEU Region Through Expert Consultation and Transition Support from Paper to Electronic Submission Format

A US-based multinational company had faced multiple Regulatory challenges with eCTD submission compliance in the EAEU region. They had turned to Freyr for comprehensive consultation support. Freyr's meticulous approach resolved their compliance concerns, resulting in rapid turnaround times, zero errors, and enhanced Regulatory efficiency.

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Freyr Provided Comprehensive Regulatory Support for Managing Partial Change Applications, Renewals, and Variations for a Global Healthcare Company in China and Japan
Publishing and Submission

Freyr Provided Comprehensive Regulatory Support for Managing Partial Change Applications, Renewals, and Variations for a Global Healthcare Company in China and Japan

A global healthcare company required comprehensive Regulatory support for managing over 40+ submission operations for their gynecological products in China and Japan. They had turned to Freyr, who provided end-to-end submission services. Freyr efficiently managed the high volume of submissions, enhanced the company's operational efficiency, and ensured Regulatory compliance.

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Celebrating Customers Success

 

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​