DDReg Pharma Pvt Ltd
Information
DDReg Pharma is a globally renowned regulatory and pharmacovigilance service provider specializing in Regulatory Strategy & Expert View Consultation, Regulatory Operations, Pre-submission expertise, Regulatory Life- cycle management service, Regulatory Software Services, Labelling Management, Regulatory Intelligence, Certification Services, Local & Health Authority Support, Scientific Services, Medico-Regulatory & Safety Writings, MA Holding Service, IPR Support, Pharmacovigilance Service and regulatory clinical trial management services.
DDReg has offices in the USA (Delaware), India (Gurgaon and Mumbai), Germany (Köln), and Singapore. Incepted in 2009, it has been providing Life Sciences, Pharmaceutical, Biotech, and Consumer companies with end-to-end regulatory and safety compliance services. DDReg has worked alongside 120+ regulatory agencies to cover US, EU, UK, LATAM, GCC, MENA, Africas, ASEAN and CIS regions. It brings rich subject-matter expertise & industry experience to support rapid market access, regulatory compliance, and lifecycle management for a range of pharmaceutical and allied products. These include generics, biologics, biosimilars, vaccines, medical device & combination products, cosmetics, dietary/food supplements, etc.
Our regulatory services includes regulatory strategies/expert views, new product authorizations, gap analysis & remediation, regulatory due diligence, API/DMF support, CMC advisory, post-approval lifecycle management, medico-regulatory writing, and legalization/notarization/apostille of legal & regulatory documents.
Our pharmacovigilance capabilities include ICSR processing & submission, literature monitoring, risk management, audit & compliance, signal management, global QPPV services, development and submission of aggregate reports, clinical safety and global pharmacovigilance intelligence.
We offer clinical regulatory support to our customers in developing robust and comprehensive clinical regulatory strategies for clinical trial application submission to the USA, EU, ASEAN, MENA, LATAM regions. The team’s expertise also lies in authoring, compiling, reviewing, and submitting clinical trial application packages.
