SME
Description
Radaydrug is R&D, regulatory and safety service integrator established in 1998 by pharmaceutical professionals with the aim of becoming a distinguished service provider across key areas of the pharmaceutical and medtech industries. We offer comprehensive support throughout the development and entire lifecycle of medicinal products and medical devices.
Over the years, we have attracted numerous talented and dedicated experts, accumulating extensive experience and knowledge. This expertise has been consolidated into a knowledge center, serving clients in the pharmaceutical and medtech sectors while also gained special domain knowledge of development or radiopharmaceuticals and vaccines.
Over the past 25 years, our team of experts has managed more than 200 product development projects and 7,500 regulatory procedures across 33 countries on behalf of 150 clients. Additionally, we have supported the conduct of over 50 clinical trials and handled pharmacovigilance (drug safety) tasks for more than 1,000 products.
Scope of Services:
• Pharmaceutical Regulatory & Development Services:We provide end-to-end support for pharmaceutical product development, registration, and lifecycle management, including:
• Dossier audits, building and compilation End-to-End Module 3 development
• Formulation and production development support with Data-to-Dossier CMC integration
• Coordination of international registration procedures (DCP, MRP, CP) and Lifecycle management and authorization maintenance
• Clinical Trial Safety and medical assessment management
• Medical and safety document preparation, IMPD building
• Pharmacovigilance system set up and maintenance with full EU coverage: We offer extensive expertise across various therapeutic modalities, including small molecules, biosimilars, vaccines, medical devices, and dietary supplements.
• GMP/GVP Audits, mock-inspections, trainings
Main activity: R&D, regulatory and safety services
Other activity: Regulatory and safety services
