DDReg is an India based Pharmaceutical Regulatory and Pharmacovigilance services provider. ISO 9001:2008 certified (by TUV-SUD), DDReg is involved in a wide variety of regulatory consulting & pharmacovigilance assignments which span across global markets and include, European Union, The USA & Australia among developed markets to Asia, Africa, Middle East, Russia, CIS and LATAM among the emerging markets.
DDReg helps pharmaceutical companies to
1) manage their regulatory affairs portfolio by way of Regulatory Strategies, Feasibility Studies, Dossier compilation and filings, Agency follow ups & approvals, Post Approval License Management, Regulatory Compliance, Gap Analysis and Regulatory due diligence AND
2) comply to worldwide safety obligations by way of managing their Adverse Event processing, Aggregate reporting, Literature Search and Signal Management.
DDReg is led by professionals with combined industry experience of >60 years in handling Regulatory Affairs and Pharmacovigilance functions. DDReg has efficient RA & PV structures with experienced groups handling assignments and projects of diverse nature. Robust processes and working guidelines have developed & implemented that are designed to comply to Global Regulatory & Pharmacovigilance Practices.