A U.S.-based manufacturer had deficiencies in their abbreviated new drug application (ANDA) as it caused the U.S. FDA to Refuse to Receive (RTR) the ANDA. If additional material was submitted to correct the deficiencies, then the amended ANDA is considered a new ANDA submission and is subjected to pay a new ANDA fee. The manufacturer approached DDReg to avoid deficiencies in ANDAs.
The objective was to establish a procedure by which legibility issues are identified and hence one of causes RTR are prevented.
DDReg’s team of experienced professionals conducted meticulous review to identify the root cause of the rejection, which was due to legibility checks. They collated their regulatory intelligence and knowledge base to devise a comprehensive legibility checklist that addressed all the necessary parameters for functionality checks. They created the checklist on Microsoft Excel for ANDA in the United States, which they could use globally.
By creating the legibility checklist, DDReg was able to create a standard which they implemented to ensure the next processes operated smoothly and avoided rejections. Files were accepted and time & cost were saved.
DDReg’s meticulous and detailed approach in creating a legibility checklist proved to its customers that DDReg’s team are experienced and pay attention to detail. The customer was impressed by the level of dedication and comprehensiveness provided by DDReg.