Overview

In an ever-evolving dynamic regulatory environment, new directives and regulations are increasingly posing real-time challenges for companies to effectively navigate the Middle East and Africa’s Regulatory submissions’ landscape. Added to that, efficiently managing eCTD formats, documents and dossiers throughout the lifecycle can severely stress a company’s resources, budgets, and the overall process of necessary eCTD conversions for electronic baseline submissions targeted towards the Middle East and African Health Authorities within short timelines. Be it the submission of an export application for medical product registration, or renewals, it is imperative for the company to have a clear understanding of the submission guidelines for Middle East and Africa region and adhere to the same.

With a strong regional presence in Dubai, UAE, Freyr brings the expertise to provide flexible, end-to-end eCTD publishing services to enable companies effectively meet all their specific and unique submission requirements for the approval of drugs, biologics, cosmetics, food supplements and medical devices. Right from dossier development, planning, tracking, publishing and submitting final documents to HAs to delivery confirmation/acknowledgment, Freyr streamlines the entire SFDA submission management process ensuring error-free, timely and quality regulatory submissions throughout the Lifecycle.

Apart from the baseline submissions, Freyr’s publishing and submission expertise span across the other HA’s submissions types such as: IND, NDA, ANDA, BLA, and DMF submissions; MAA, CTA, ASMF Submissions; NeeS Submissions; PBRER; PADER; SPL (Structured Product Labeling) Submissions; and Regulated Product Submissions(RPS).

Freyr also assists clients to meet the Regulatory submission needs with respect to the SFDA, EDA, JFDA, Israeli MoH, Oman MoH, Turkey MoH, UAE MoH, and Yemen’s SCDMA. 

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Freyr Capabilities

Region-wise Dossier Development Plan / Submission Planning and Life Cycle Management/ Geo-Specific

  • Expertise across Submission formats for eCTD, NEES and Paper across
  • Multi-country compliant regulatory submissions for: Saudi Arabia, UAE, Oman, USA, EU, Canada, SA, Switzerland, Australia, New Zealand, , and Rest of the world.
  • Document mapping across regional submissions
  • Sequential relationship building for submissions, and variations
  • Converting Non-eCTD electronic format (NeeS format) or paper format to eCTD format
  • Using appropriate eCTD versions inclusive of accurate eCTD Modules, eCTD Formats, and eCTD Structure
  • Expertise in paper to eCTD transformation, Non-eCTD to CTD format and Gap Analysis
  • Dedicated compliance group for specialized US agent service
  • Support for creating gateway for US ESG (FDA Electronic Submissions Gateway) and EU CESP (Common European Submission Portal)
  • Submission map for all application types for tracking major submissions

Submissions Document Development and PManoublishing

  • Managing and processing source documents
  • Insertion of navigation aids
  • Managing source documents in a secure and web-based regulatory document management system
  • Publishing of Case Report Forms (annotated and hyperlinked)
  • Creating submission-ready documents
  • Document level & report level formatting as per respective HA guidelines
  • Consultative support

Submissions Compilation / Dossier Compilation

  • Module creation
  • Cross-functional document tracking
  • Metadata compilation/template management
  • Dossier Lifecycle management
  • History management
  • Leaf documents compilation
  • Study Tagging Files (STF) creation, and management
  • Validation using appropriate Industry-accepted / Agency-recommended tools

Quality Review and Delivery / Publishing

  • Step-wise validation of the packages
  • Backbone XML Validation
  • Checksum Verification
  • Thorough QA/QC of modules and dossiers
  • Metadata verification with respect to country specific regulatory requirements: Saudi Arabia, UAE, Oman, USA, EU, Canada, SA, Switzerland, Australia, New Zealand, , and Thailand
  • Burn CD/DVD master
 

Freyr Advantages

  • Robust eCTD Structure built on acknowledged standards
  • Upgraded tools to review electronic regulatory submissions to offer sturdy performance
  • Consolidated formation offers transparency to regulatory submissions
  • Simple tools integrated for eCTD publishing services
  • Quick and affordable implementation
  • Dedicated project management team and subject matter expert for each submission types
 

Accelerating Ahead Of Competition Delivering Faster Time to Approval 

Freyr helps a global client with fast-track ANDA submission within 3 weeks, increasing in cost benefits by 70%.
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Freyr SUBMIT

Freyr SUBMIT

Freyr SUBMIT is a complete eCTD software product for the creation, validation, publishing, viewing and reporting of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities.

Learn more about Freyr’s eCTD Submission Solution

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