“DDReg – since its inception in 2009 has proven to be the trusted partner of the leading Pharmaceutical Companies to manage their regulatory affairs portfolio by way of Regulatory Advisory on Entry Strategies, Technical compliances andrequirements, Feasibility Studies, Dossier compilation & submissions. We’re also an astute partner who can help simplify that journey for our clients to get the registration of their product more quickly. We aim to provide quality with passion”
DDReg is an India based Regulatory and Drug Safety Services organization. It is ISO 9001:2015 certified by TUV-SUD for its Quality Management System. It is involved in a wide variety of regulatory consulting, advisory & operational assignments which span across global markets that include key markets like USA, UK & European Union, ASEAN and Africa.
DDReg has, rich experience of handling ANDA and ANADA filings to US FDA as well as DCP/MRP procedures in EU. The working level teams at DDReg have carried out extensive due diligence activities of technical documents, gap analyzed the documentation, developed and authored the CTD Modules for submission to FDA, EMA & UK MHRA, published eCTD modules using established publishing tool and have submitted the dossier & applications using electronic submission gateway. DDReg is consulting partner to Extedo (Munich, Germany).
DDReg has helped pharmaceutical companies to manage their regulatory affairs portfolio by way of Regulatory Advisory on Entry Strategies, Technical compliances and requirements, Feasibility Studies, Dossier compilation & submissions, Agency follow ups, approvals. It has successfully supported organizations for their requirement of Post Approval Life Cycle Management by managing post approval Compliances, Gap Analysis and Regulatory due diligence. DDReg’s Product Scope so far include Generic Pharmaceuticals (Human Drugs), Generic Pharmaceuticals (Veterinary Drugs), Cosmetics and some Food supplements.
DDReg has processes par excellence, Committed bunch of RA Professionals and efficient IT systems & databases for dossier management & submission
Functional Expertise stands tall on Standard Operating Procedures & Working Guidelines that define global RA standards. Processes are in place for consistent monitoring & tracking of global RA Regulations/Guidelines (US FDA Guidance, EMA regulations, WHO, ICH, African & ASEAN RA Practices)
Operational Excellence is manifested through strong Quality Management System, and Efficient Project Management. In span of 9 years DDReg has carried out Regulatory Due Diligence of about 500 dossiers, resulting in successful submissions, approvals and launches for its esteemed clients.
DDReg is led by Experts with combined experience of ~ 60 years in handling product development, RA & Medical writing work. Efficient Structure with experienced groups handling each stage of product life cycle, is the hallmark of human resource at DDReg. Extensive trainings on all critical aspects of RA (e.g GMP – PIC/s, WHO, Quality Monitoring, Dossier Management, Medical Writing, ICH requirements etc.) are provided to the staff. DDReg has well developed training Calendar to enrich the technical knowledge of its technical team.
It was founded by Ms Neeti Pant, she worked in the scientist position with one of the top pharmaceutical company. DDReg was established with ardour to bring together regulatory, safety, medical, and technology resources.