Business Imperatives

  • An Italy-based multinational company, specializing in Innovator products, sought to expand its market presence in the European Union (EU) and the United States (USA).
  • The client sought Freyr as a Regulatory partner to facilitate market entry in the EU and USA for their Innovator products.
  • Support was required in various submissions, including NDA, MAA, IND-LCM, DMF, and pre-submission requirements.

Objectives

The objective was to provide the client with comprehensive assistance in various submissions and pre-submission requirements, enabling them to enter the markets in the EU and USA with their innovator product used in the treatment of arthritis and muscular dystrophy.

Problem Statement

  • Lack of in-house Regulatory expertise in US FDA/EMA requirements.
  • Absence of Regulatory oversight over IND activities for oral suspension formulation internally.
  • Lack of understanding of pre-NDA/MAA requirements, such as facility establishment registration and drug product naming conventions.

Freyr Solutions and Services

Freyr Solutions and Services
  • Conducted gap analysis to identify areas needing improvement.
  • Interacted with health authorities to address Regulatory concerns.
  • Assisted with publishing and submission processes.
  • Supported NDA, MAA, IND, and DMF submission activities to ensure compliance and efficiency.
  • Supported health authority interactions and offered Regulatory strategic guidance on drug development.
  • Offered customized submission checklists tailored to specific project needs.
  • Assisted with module preparation for NDA & MAA submissions.
  • Supported maintenance activities of the IND, including SUSAR notifications, DSUR, etc.
  • Aided with the submission of facility establishment registration.
  • Accelerated HA interactions led to timely approvals.
  • Right skill set engagement in NDA/MAA submission improved quality and efficiency.
  • Reduced submission efforts by re-using NDA sections for MAA.
  • IND monitoring as per the latest HA requirements ensured compliance and minimized risks.

The client was provided with comprehensive support for NDA, MAA, IND, and DMF submission activities, enabling them to enter the markets in the EU and USA markets with their innovator product for treating arthritis and muscular dystrophy.