Business Imperatives

The client needed support for initial submissions such as INDs, IMPDs, NDAs, and MAAs, develop effective Regulatory submission strategies, facilitate market expansion submissions for new regions, manage post-approval lifecycle submissions and change control evaluations and support the organization of samples and certificates to meet Regulatory requirements

Objectives

To support an Innovative Medicines Company in achieving Regulatory compliance and market expansion goals by managing all aspects of submissions, approvals, and lifecycle management with precision and expertise.

Problem Statement

  • The client faced difficulties in meeting strict submission timelines due to complex Regulatory requirements.
  • Encountered challenges in managing and updating products across multiple countries with varying regulations.
  • Experienced hurdles in tracking and updating databases to maintain accurate submission and approval records.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr also provided a diverse set of services that included:​

  • Supported CMC, publishing, and Regulatory operations by deploying resources at the client’s location for seamless program execution.
  • Ensured the database for registered dossiers was updated regularly to maintain compliance and accuracy.
  • Coordinated with country managers and stakeholders to obtain source documents and ensure timely submissions.
  • Reviewed supporting documents and data, providing detailed reports to identify and recommend additional data generation where needed.
  • Prepared dossiers using client-specific CTD templates, reviewed and finalized submission packages for Regulatory compliance.
  • Managed the publishing and submission of Regulatory packages to health authorities through electronic gateways as applicable.
  • Conducted gap analysis of existing dossiers to identify discrepancies with country-specific requirements, updated dossiers, and submitted them to agencies.
  • Assessed change controls, developed variation strategies, and submitted variation packages to health authorities.
  • Identified and executed actions required to address Regulatory compliance gaps, including coordinating with R&D for necessary data generation.
  • Liaised with health authorities, authoring and submitting responses to Regulatory queries efficiently.
  • Updated the database with accurate submission and approval statuses to support effective tracking and compliance reporting.

Freyr successfully supported an Innovative Medicines Company in achieving Regulatory compliance and market expansion goals by managing all aspects of submissions, approvals, and lifecycle management with precision and expertise. This included ensuring timely submissions, addressing compliance gaps, and streamlining Regulatory processes to facilitate seamless entry into new markets.