Overview

Global Dossier Management implicates tasks that are driven under strict timelines coupled with high-level coordination across local markets to help companies expand their prospects in targeted geographies. If it is to be dealt in the case of pharmaceutical imports and exports to UAE and MENA region, handling huge volumes of dossiers pertaining to registration, licensing, renewal and baseline submissions pose a real-time challenge for companies during compilation and managing affecting the approval time and market entry.

At the same time, approved products constantly undergo changes pertaining to chemical composition, manufacturing process, transfer of manufacturing sites, labels, shelf-life extensions etc. While seeking import, export and distribution licenses or certificates in the MENA region, many of those findings must be reported to Ministry of Health or geo-specific health authorities. Here comes the need of exclusive lifecycle management (LCM) services.

With a strong presence in MENA region, Freyr brings a clear-cut regional understanding of both dossier management and life cycle management (LCM) regulations. Having a firm grip over dossier management and LCM services viz. renewals, variations / amendments submission activities, our Regulatory experts offer right-first-time approach to avoid further data generation/modification enhancing the Regulatory perfection for our clients. Freyr provides robust preparation and execution strategies for dossier management and tracks each aspect of LCM (from product launch to patent expiry) and support our clients with defined strategies with the scope of a minimum number of queries from the regulatory authorities.

Freyr assists clients to meet the Regulatory dossier management requirements across MENA region for GCC and Non-GCC countries as well. Freyr is well-versed with following Regulatory agencies: SFDA, EDA, JFDA, Israeli MoH, Oman MoH, Turkey MoH, UAE MoH, and Yemen’s SCDMA.

Click here to know more on our local expertise.

 

Freyr Capabilities

Dossier Management

Pre-submission Consultation for Client

  • Project Planner Preparation and guiding client during execution for regulatory requirements
  • Preparation of dossier checklist for baseline submissions
  • Correspondence with the SFDA

Gap Analysis to Submission Documents

  • Gap analysis for available documents
  • Preparation of Freyr assessment report and remediation
  • Assisting Client in generation of missing data as per the guidelines
  • Collection of final documents 

Preparation, Review & Submission

  • Compilation of modules as per the SFDA or competent HA submission requirements
  • Quality Check
  • Final Review by Client
  • eCTD sequence creation

Response to Queries

  • Queries and assessment reports from client
  • Freyr assessment of reports & gap analysis
  • Finalising the strategy in the preparation of response to queries
  • Coordination with client for generation of data
  • Review for quality checks
  • Response drafting
  • Publishing of next eCTD sequence
  • ESG submission

Post-Approval Management

  • Freyr assessment and gap analysis
  • Finalization of filing strategy
  • Preparation of checklist on type of filing
  • Collection of final documents
  • Preparation and compilation of amendment & Renewals
  • Freyr review and quality check
  • Publishing & Submission

Lifecycle Management

Global CMC Services

  • End-to-End product or franchise responsibility for Global CMC activities associated with the products or product categories
  • Regulatory Dossier Preparation for Variations & Renewals
  • CMC Gap Analysis
  • Response to Health Authority questions & Health Authority interactions
  • Manufacturing Site Transfers, Additions, shut-down
  • Preparation, Revision, Review module-wise dossiers

Registrations and License Management Services

  • Registrations & License Renewals for MENA region (including the Middle East and North Africa regions)
  • Registrations & License Renewals for global regions (including regions like Eastern Europe, Russia, Asia Pacific, Africa)
  • EU – Specific Services related to MRP, DCP, National Licenses (e.g. Extension of National License to MRP License)
  • Re–registrations / Renewals
  • Global Registrations / License tracking & management

CMC Change Control Coordination Services

  • Evaluation of Change Controls for MENA, CIS, APAC, Africa, US & EU regions
  • Product Quality Reviews & Annual Product Reviews
  • Ongoing monitoring of Changes made to Products, throughout the year
 

Freyr Advantages

  • Evaluation of documentation as per the recurrent changes in drug constituent and drug manufacturing sites
  • Annual reports and renewals to ensure sustained market access for a company’s product line
  • Progressive functioning models to provide certainly and at scale by influencing external assets
  • Global service delivery competence
  • Round the clock support
  • The concept of “first-time-right” outputs to ensure timely approvals
  • Regulatory consultation & strategies for faster approval
  • Streamlined harmonization for multiple markets
  • Minimalized correction cycles
  • Detailed tracking and assessment of variations & renewals (LCM)
  • Significant cost savings
 

Sales of $100s of Millions Successfully Ensured For Top 20 Global Brands in EMEA & CIS Markets

Freyr helps a global client ensure $100s of Million in Sales continuity for Top 20 brands through on-time CMC services.
Download