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  • Complex Regulatory and Pharmacovigilance data processed, interpreted and converted to quality information that comply to global requirements

  • Quality is in DDReg‘s DNA

  • Product Quality & Safety defined through robust & compliant procedures and working guidelines

  • Strong Intellectual foundation @ DDReg for a stable future

  • At DDReg knowledge advances as technology advances each day

  • Efficient Regulatory and Pharmacovigilance roadmaps to achieve success in global markets

About Us

DDReg is an India based Pharmaceutical Regulatory and Pharmacovigilance services provider. Certified ,  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. 


Our Services

Strategy

Regulations related to drug & drug products continue to pose a major challenge for the global pharmaceutical and allied industry. In such situation – a sound regulatory strategy is key to th...

Operations

Any sound regulatory strategy stands on effective planning and implementation. Regulatory Operations by way of New Filings, dossier compilations or variations, running procedures on client’s beh...

Post Approval Life Cycle Management

Post approval Life Cycle Management (PLM) includes the lifecycle of a product once it has been launched in the market. It is about the maintenance of the product in the market in compliance to the reg...

Medical Writing

DDReg undertakes writing of various medical documents that form part of submission dossiers or required for maintaining post marketing safety documentation. DDReg has a team of experts who have experi...

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