DDREG Pharma

DDReg Pharma is a leading global consulting firm specializing in regulatory solutions, pharmacovigilance (drug safety), and quality assurance for the Life Sciences industry (Pharmaceutical, Generics, Biopharmaceuticals, Medical Devices, and Consumer Health

Key Services & Areas of Expertise:

 

• Regulatory Affairs: Strategic planning, dossier preparation and submission (CTD/eCTD), New Product Authorizations (NPAs), and lifecycle management across global health authorities (e.g., FDA, EMA, CDSCO).

• Pharmacovigilance (PV): Comprehensive drug safety services, including adverse event monitoring, risk management planning, QPPV deployment, and PV system audits to maintain global safety compliance.

• Quality & Compliance (GMP): Expert services to elevate manufacturing standards, conduct GMP audits, perform gap analysis, and implement risk-based quality assessments.

• Regulatory Intelligence & Technology (Reg-Tech): Leveraging advanced, in-house AI-driven platforms and Regulatory Information Management Systems (RIMS) to provide strategic regulatory insights and streamline complex processes.

• Additional Services: Clinical Regulatory Services, Medical Writing, IPR (Intellectual Property Rights) Support, and Toxicology Solutions.