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Regulatory solutions & services for Life Sciences industry

Hybrid Applications

Overview

Registration of the Marketing Authorization Application (MAA) for a generic product with changes in active substance(s), therapeutic indications, strength, route of administration compared to the reference medicinal product is very complex as the MAA relies on pre-clinical and clinical trials data with respect to the reference product and new data. In such scenario, bridging studies are critical to show the equivalency with the reference medicinal product for on-time registration and receipt of approval for hybrid application through Article 10(3) from EMA/EU Health Authorities.

Freyr, with wide experience in handling MAA submissions for hybrid applications (Article 10(3)), acts as a cost-effective and trust-worthy Regulatory partner to pharmaceutical manufacturers/Marketing Authorization Holders (MAHs) in-order to handle all legal and administrative requirements, along with registration activities, for the medicinal products.

Freyr Expertise

  • 01

    Preparation and review of study designs to be performed for bridging studies

  • 02

    Pre-submission meetings with the EMA or with other EU Health Authorities

  • 03

    Preparation and support of submission packages for scientific meetings with the EMA/EU Health Authorities

  • 04

    Regulatory submission road map/way forward for generic and hybrid applications

  • 05

    Selection of dissolution parameters/multimedia for performance of dissolution for test product and RMP

  • 06

    Support in the preparation of product development report (discriminatory nature of media)

  • 07

    Finalizing the specifications for finished products, in-process/intermediates and review of protocols/reports for exhibit batches/stability study

  • 08

    Assistance in selection of Regulatory submission procedure i.e. Centralized Procedure (CP), National Procedure (NP), Decentralized Procedure (DCP) or Mutual Recognition Procedure (MRP)

  • 09

    Slot booking for MAA submissions

  • 10

    Liaise with country HA to act as RMS for MAA filing in DCP

  • 11

    Technical gap analysis of source documents/data for adequacy against EU countries specific requirements

  • 12

    Compilation, technical review, finalization, publishing and MAA submissions in eCTD format

  • 13

    Regular follow-ups with Health Authorities

  • 14

    Handling Health Authority (HA) queries with strategies and preparation of response package for submission for marketing authorization approval

  • 15

    Translation support during the national phase of the registration in all EU languages

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