Consulting and Real-World Evidence (RWE) Services
Consulting and Real-World Evidence (RWE) services encompass all essential activities required for a successful market entry. While the US and European markets are commercially attractive due to their size, price levels, GDP, and purchasing power, they present numerous challenges and differences, especially for newcomers.
DUBA & Partners will guide you through this process and support you every step of your journey. If you need to register your medical devices, explore reimbursement options, organize a clinical trial or real-world data project, analyze the competitive landscape, or develop a pricing strategy, our team is here to support you.
The scope of Consulting and RWE services:
FDA Marketing Authorization and EU MDR and CE mark
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Feasibility analysis for setting the strategy, especially with regard to the classification of the given medical device
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Preparation of the dossier for submission
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Preparation of statements and amendments on request
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Payment processing (in the USA, mainly with regards to the Medical Device User Fee Amendments (MDUFA)
Clinical trials and RWE projects
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Premarket clinical studies conducted under Investigational Device Exemptions
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Premarket approval applications (PMAs)
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Post-marketing studies
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Registries
Market Entry Readiness
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Market research and analysis to evaluate commercial potential, opportunities, and threats
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Competitive landscape analysis
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Analyzes of price sensitivity for setting a competitive price policy
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Preparation of business plans for the US market/ EU market
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Establishing initial cooperation and relations with key entities (health facilities, opinion leaders, research institutions, insurance companies, distributors, etc.)
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Securing the duties of the U.S. agent in accordance with legislation
Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR, Subchapter H). The regulatory controls and marketing pathways are based on the risk of the device and the regulatory controls needed to ensure reasonable assurance of safety and effectiveness.
