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RegIntel – Regulatory Intelligence Platform

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DDReg Pharma, a Global Regulatory Solutions and Safety Services organization is based out of Delaware in the US. The delivery of services currently happens from their India offices. They have a presence in Mumbai, Hyderabad, and Gurgaon. Incepted in the year 2009, the company is involved in a wide variety of regulatory & drug safety assignments across global markets. Rich subject matter expertise is combined with cutting-edge technology solutions providing end-to-end support across the pharma value chain. The company supports global pharmaceutical organizations in their needs to address regulatory challenges regarding Biologicals, Complex formulations, INDs, NDAs and Generics, Consumer Healthcare Products, and Medical Devices, in highly regulated markets as well as in complex emerging markets. The services portfolio includes Document management, Dossier support, pre-Approval, and Post MA regulatory support, Submission management, Regulatory Intelligence, Regulatory Strategies, Feasibility Studies, Dossier compilation, submissions, Agency follow-ups, and approvals. The Drug Safety Vertical supports global organizations in managing their worldwide Safety Obligations by way of Case Management, Aggregate Reporting, Safety Compliances, Signal Detection, and Risk Management. Functional and Operational Excellence are manifested through Strong Quality Management System and Efficient Project Management.

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