Mohammed Shethwala Email and Phone Number

RegEnd Solutions is an established venture founded by team of experienced professionals of pharmaceutical industries who will provide end to end solution to your regulatory needs. A passionate team of dedicated people with clear vision, accurate planning and immaculate execution process help client for early access of the market of the product by providing tailored made solutions and diverse regulatory tactics.

Responsible for execution and implementation of project as per scheduled deadlines. Execution and management of dossier extension activities for external client. Looking after submission management of Abbreviated new drug application, National Procedure, Mutual Recognition Procedure and Decentralised Reliance Procedure (MRDCRP) and Decentralised Procedure (DCP). Technical review and evaluation of development as well as production related documents. Look after the co-ordination… Show more Responsible for execution and implementation of project as per scheduled deadlines. Execution and management of dossier extension activities for external client. Looking after submission management of Abbreviated new drug application, National Procedure, Mutual Recognition Procedure and Decentralised Reliance Procedure (MRDCRP) and Decentralised Procedure (DCP). Technical review and evaluation of development as well as production related documents. Look after the co-ordination related activities with cross functional teams for technical documents as and when required for submission.Technical query compilation and response after thorough evaluation & consideration of technical as well as current regulations. Submission management of CEP / ASMF applications (new application and revision application) for EDQM submission. Review and submission of Product life cycle management (LCM) activity including management of the variations.Actively involved in preparation of scientific advice meeting package, briefing documents for agency submission. Excellent technical review and evaluation skills of developmental as well as production related documents like BMR/BPR, Dissolution development report, finished product specification, Testing procedures, PDR, COAs, API DMF, Stability data, Stability protocols, Sampling protocols as regulatory authority. Show less

Responsible for preparation of study designs for various drugs depending upon regulatory regions. Preparation of protocols, ICF’s and CRF’s for various drugs depending upon regulatory region like US- FDA, UK- MHRA, Health, Canada, DCGI- India and Japan for BA/BE studies. Coordinating the IEC to get approvals for protocols, ICF’s and CRF’s and maintaining corresponding documents of IEC. Coordination with Sponsor’s for preparation of BA/BE protocols including actual conductance of the studies.