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Services:
Our key activities are organized along the lines of the most important challenges that entrepreneurs (at any stage of their ventures) face when launching new products to the Healthcare Markets where convergent technologies bring disruptive value propositions.
Our Goal is to enrich our client's team to plan (Calibrate) and Execute (Business and Clinical Interim Operations) growth projects.
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Clinical Value Creation
- Clinical Value Proposition Validation / Clinical Relevance
- Clinical Evaluation Plans (Key end points/outcomes, patients sample size)
- Search and recruitment of Clinical Sites
- Estimates of budgets and timelines for clinical collaborations
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Product "regionalization"
- Users Advisory Boards to validate / adapt key product features
- Multi Generational Planning for US Market Entry (and FDA submission)
- Product Liability Assessment and insurance
- Order-to-Remittance process mapping and gap analysis
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Regulatory Assesment
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High Level/preliminary regulatory strategy (class/timeframes/clinical needed)
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Need for clinical data: are existing data sufficient ?
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US FDA regulatory compliance, for device, software and combinations
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Gap analysis to FDA submission preparation and filing
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| Market Opportunity Calibration
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Market Clinical Segmentation and Attractiveness
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Market Segment Profiling, Opportunity mapping
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Market Access Strategy
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Partners / first deal search and execution
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| US Healthcare Economics
- Reimbursements Assesment and opportunities
- Need for Economic Trials ?
- Business Model assesment ( Pricing, Marging distribution, Cost structures, Taxes and FX)
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| Venture Funding
- Grants, Seed, Angel, VC funding opportunity search
- International and Foreign Trade Funding Strategies
- US State and Entrepreuneur assistance programs
- NHI / SBA funding opportunity search
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Executive Interim Management
- US Executive presentce / interim CEO roles
- Interim Clinical Leadership / CMO roles (ex: clinical trials supervision)
- Sales Force coaching and development, business operations
- On-demand Lead Generation campaings
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Local Team Build-up
- Organizational structure definition, job descriptions, objectives
- Sales Force deployment and compensation plans
- Payroll and Benefits (with Partners)
- Executive Search and pre-selection (sometimes with Partners)
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Corporate Identity Creation (with select Partners)
- Selection, formation and operating agreement of US legal Structure
- Virtual offices, incubator or full office selection
- Comprehensive Accounting Management Services
- Collateral creation, web presence and Industry Associations enrollment
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