A generic medicinal product is therapeutically equivalent to its innovator/branded drug with respect to quality, safety, and efficacy, and is a low-cost alternative. Being a potential generic medicines market, the United States encourages generics manufacturers to expand their product footprint in the U.S by registering Abbreviated New Drug Applications (ANDA) through the 505(j) (ANDA filing procedure/process) route.
However, considering the US FDA’s ever-evolving ANDA submission requirements, it is challenging for manufacturers to decode the guidelines and adhere to specific requirements such as product development by QbD approach, Module 2 in QBR format, and the GDUFA program implementation. Due to this, it has become necessary for manufacturers to involve Regulatory experts from the initial product development stage for timely registration, quicker approval, and life cycle management.
Freyr is a trustworthy Regulatory partner for cost-effective, RTR (Refuse-to-Receive) compliant, and on-time submissions and approvals. Freyr can play a key role in speeding up the US FDA review process of an ANDA application. With a clear-cut understanding of the ANDA submission requirements and a holistic risk management approach, Freyr helps you explore the shortest route and timeframe to put your products in the market safely, aiming at ultimate commercial success. Freyr’s capabilities for ANDA application submissions include:
- Strategic support for ANDA submission roadmaps/ANDA filing procedure and supporting document generation.
- Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard, review of specifications for APIs/in-process controls/finished product, product development report using QbD principles, process validation protocol/report, stability study, compliance to IIG database, Q1/Q2 compliance for parenterals, otics, & ophthalmic, and guidance on batch size requirements.
- Preparation/review of ANDA submission strategy and guidance on risk mitigation plans.
- Pre-submission FDA interactions and walkthrough support in control correspondences.
- Pre-submission administrative activities like facility identification, request for DUNS/FEI/ANDA Application numbers, etc.
- Sharing of Abbreviated New Drug Application (ANDA) documents checklist.
- Gap-analysis/Regulatory assessment of generated source data for Regulatory adequacy.
- Guidance on the generation of additional/missing documents for Refuse to Receive (RTR)/GDUFA compliance.
- SPL submission for facility establishment, drug listing, and for their renewals.
- Compilation of quality ANDA package as per the current FDA and RTR requirements, publishing, and submission in the eCTD format via the FDA ESG.
- Interaction/follow-ups with the US FDA for the ANDA approval.
- Support in resolving critical RTR (Refuse-to-Receive) issues.
- Regulatory strategy and response preparation for queries (IRs/DRL/CRLs) during the ANDA approval process.