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.
USA
UK
GERMANY
INDIA