Business Imperatives

  • An Italy-based pharmaceutical organization encountered a Regulatory dilemma regarding their injectable drug product.
  • The client sought support from Freyr to devise an appropriate strategy for contacting the US FDA to understand their expectations.
  • Freyr helped the client obtain a product development meeting (PDM) with the US FDA to clarify the HA's requirements for developing a complex generic product.

Objectives

The objective was to offer comprehensive Regulatory support in the US market for the complex generic injectable product, ferric carboxy maltose injection, aimed at treating iron-deficiency anaemia.

Problem Statement

  • The client lacked an understanding of the US FDA's expectations regarding the development of complex generic products.
  • The client was unclear about the bioequivalence (BE) study requirements for the same product with different strengths.
  • There was uncertainty about the requirements related to the sameness study plan.
  • The client was indecisive about obtaining an FDA agreement on the proposed specifications for one of their starting materials.

Freyr Solutions and Services

Freyr Solutions and Services
  • Provided submission guidance.
  • Offered CFR-based support.
  • Delivered end-to-end Regulatory support for a complex generic injectable product.
  • Successfully conducted an end-to-end evaluation of the RLD review summaries and included important pointers in the meeting package.
  • Provided specific CFR (Code of Federal Regulations) and guidance recommendations for each of the client’s queries.
  • Evaluated development challenges and suggested an optimal Regulatory strategy.
  • Performed document gap analysis and proposed mitigation plans.
  • Ensured responses to all development queries were received from the FDA.
  • Timely delivery of the meeting package ensured efficient communication and decision-making.
  • Clarification from the FDA on all development concerns improved Regulatory understanding and compliance.
  • Implementation of a successful PDM strategy facilitated productive Regulatory discussions.
  • The FDA evaluated and granted the meeting package to the client as WRO (Written Responses Only).
  • The successful implementation of a PDM (Product Development and Management) strategy facilitated smooth Regulatory proceedings.
  • Ensured compliance and effectiveness throughout the development of complex generic injectable products.