Abbreviated New Drug Application

Overview

The Abbreviated New Drug Application (ANDA) is an application submitted to the USFDA for the review and approval of a generic drug demonstrating bioequivalence against the already approved innovator drug so that the generic drug can be used as a safe, effective, and low-cost alternative to the brand-name drugs.

Applicants must follow the content and format, Refuse-to-Receive standards, and other USFDA guidelines for the successful approval of an ANDA during the first review cycle.

Freyr, with extensive experience in registration activities, offers end-to-end ANDA services for manufacturers/sponsors/ANDA applicants and thus, can be a preferred Regulatory partner to ensure Market Authorization Application (MAA) approval right at the first time.

Freyr Expertise

  • 01

    Preparation of Regulatory roadmap strategy for Abbreviated New Drug Application (ANDA).

  • 02

    Regulatory consultation during the drug development stage for selection of reference listed drug, evaluation of excipients against IIG database for oral drugs, and controlled correspondence submission for Q1/Q2 sameness for sterile products.

  • 03

    Review of quality by design protocols and reports and guidance on stability and bioequivalence study for ANDA submission

  • 04

    Support in pre-ANDA submission administrative activities like a request for the ANDA number, DUNS number, FEI number, labeller code, etc. from the FDA.

  • 05

    Pre-submission FDA interactions and walkthrough support in control correspondences.

  • 06

    GAP analysis/Regulatory assessment of generated source data for Regulatory adequacy.

  • 07

    Compilation of quality dossier as per the current FDA and RTR requirements, publishing, and submission of ANDA via FDA ESG.

  • 08

    Preparation of strategic risk mitigation plans for error-free ANDA submissions to ensure zero RTR.

  • 09

    Regulatory response strategy and preparation for the response with scientific justifications for HA queries (IRs/DRL/CRLs) during the ANDA approval process.

  • 10

    Critical support in resolving RTR issues.

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