Regend Solutions

RegEnd Solutions is an established venture founded by group of experienced professionals in pharmaceutical industries and provide end to end solution to your regulatory needs. Being in the pharmaceutical industry for more than 15 years, we, as an individual have established ourselves as an expert in various regulatory activities and serving the markets worldwide. We have launched our operations with passionate team of dedicated people with clear vision, accurate planning and immaculate execution process. We dream big we are totally committed to it. • Pre-submission Phase Support - Controlled correspondences, pre-submission meeting requests, facility identification, request, Scientific advice meeting- Due diligence support for dossier compilation/preparation/Bridging. • Submission Phase Support- End to end solution for Dossier submission - Preparation, review and submission of NDA/ANDAs/ MAA/CEP/ASMF in line with recent regulatory requirements- Structured Product Labelling (SPL)/Product information (QRD) preparation and review- Submission management through FDA ESG portal/CESP Portal/National Portal- eCTD preparation and submission support • Lifecycle management Support- Annual Report Filing, CBE0, CBE30 and PAS- Variation support (Type IA/IB/II)- Line extension, MAT, Sunset clause application, Renewal application.