Service providers

Drug Development and Regulation (DDR)

Solution provided
Market solutions
Supplier indentity
General description
Drug Development and Regulation (DDR) is an independent European consultancy company, focused in providing appropriate scientific & regulatory expertise for the global development and registration of Drugs and Medical Devices. Our valuable and tailor-made solutions contribute to the success of your development programs from a quality, nonclinical, clinical, and regulatory point of view. The DDR team gathers highly experienced professionals with strong scientific backgrounds, accustomed to the utmost regulatory standards to carry out any plan, including innovative products, reprofiling or hybrid drugs, amongst others. Advantageously located in Barcelona, Amsterdam & London, DDR also benefits from a large network of highly qualified experts and strategic collaborations with renowned institutions worldwide.
Type of supplier
Service Provider - Professional Advisor /Consultant / Legal / Accounting, Others
Sector of activity:
Biotechnology sector, Consulting (Other), Companion Diagnostics, In vitro Diagnostics, Medical Devices, Orphan Diseases, Pediatrics, Pharmaceutical sector, Rare Diseases, Regulatory Requirements
Activity description
Services provided
Strategic regulatory development roadmap. Gap analysis. Strategic positioning and feasibility analysis for orphan indications. Operational activities: Orphan Drug Designation in US and EU, Briefing Meetings at the EMA, Scientific Advice at EMA and national regulatory agencies, pre-IND and other meetings at the FDA, Pediatric Plan (PIP in EU and PSP in US), Marketing Authorization Application in EU and New Drug Applications in US. For medical devices: Strategic regulatory development roadmap, gap analysis, certification process, Technical Documentation
Terms of availability for SMEs
Potential conflict of interest with regard to products if DDR is already committed to a similar or potentially competing product.
Quality labels and accreditations
No.
Contact information
Name
Xavier Luria
Function
CEO and Senior Consultant
Phone number
+34935285385
Address
Consell de Cent 375
08009 Barcelona Barcelona
Spain

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