Abbreviated New Drug Application (ANDA) is an application submitted to the USFDA for review and approval of generic drug demonstrating the 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 have to follow the content and format, Refuse-To-Receive standards and other USFDA guidelines for the successful approval of 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.
Preparation of Regulatory roadmap strategy for Abbreviated New Drug Application (ANDA)
Regulatory consultation during the drug development stage for selection of reference listed drug, evaluation of excipients against IIG database for oral drugs, controlled correspondence submission for Q1/Q2 sameness for sterile products
Review of quality by design protocols and reports, guidance on stability and bioequivalence study for ANDA submission
Support in Pre-ANDA submission administrative activities like a request for ANDA number, DUNS number, FEI number, labeler code, etc. from the FDA.
Pre-submission FDA interactions and walkthrough support in control correspondences
GAP analysis/Regulatory assessment of generated source data for Regulatory adequacy
Compilation of quality dossier as per current FDA and RTR requirements, publishing and submission of ANDA via FDA ESG
Preparation of strategic risk mitigation plans for error-free ANDA submissions to ensure zero RTR
Regulatory response strategy and preparation for the response with scientific justifications for HA queries (IRs/DRL/CRLs) during the ANDA approval process.
Critical support in resolving RTR (refuse-to-receive) issues