The Abbreviated New Drug Application (ANDA) is the pharmaceutical industry’s entry point for generic medicines to demonstrate their therapeutic equivalence to innovator/branded drugs in terms of quality, safety, and efficacy, making them a more affordable option. US officials are aware of the potential of the generic medicines market, so they push for the growth of generic manufacturers by facilitating the registration of ANDAs through the 505(j) route.
Generic drug applications must go through the ANDA application and ANDA Regulatory approval processes. Nonetheless, it is difficult for manufacturers to decipher the guidelines and adhere to specific requirements like product development using a QbD approach, Module 2 in QBR format, and the implementation of the GDUFA program, all of which are mandated by the US FDA as part of ANDA submissions. Manufacturers must include Regulatory Affairs professionals in the initial stages of product development to ensure smoother registration, faster approval, better life cycle management, and an easier ANDA filing process.
Regarding timely, low-cost, and RTR (Refuse-to-Receive) compliant submissions and approvals, E&E Medicals is the dependable Regulatory partner you need. An ANDA application reviewed by the US FDA can be sped up with the help of E&E Medicals. E&E Medicals helps you find the fastest and safest way to get your products to market so that you can achieve your business goals by thoroughly understanding the ANDA submission requirements and a comprehensive risk management approach. The following are some of the things E&E Medicals can do regarding ANDA submissions.
Strategic assistance with ANDA submission roadmaps, ANDA filing process, and ANDA submission-related document generation.