Chetan Borkar's Contact Details

Chetan Borkar's Company Details

DDReg Pharma

Gurgaon, Haryana, India • 47 Employees
Pharmaceuticals

DDReg Pharma, a Global Regulatory Solutions and Safety Services organization are based out of Delaware in the US. The delivery of services currently happens from their India offices. They have their presence in Mumbai, Hyderabad and Gurgaon.Incepted in the year 2009, the company is involved in a wide variety of regulatory & drug safety assignments which span across global markets. Rich subject matter expertise gets combined with cutting edge technology solutions providing end to end support across pharma value chain. The company supports global pharmaceutical organizations for their needs to address regulatory challenges pertaining to 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 to manage 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.