VENTURE CAPITAL DUE DILIGENCERegulatory affairs and clinical trial design & management
RCRI® understands the importance of regulatory and clinical strategies in a company’s business model. We offer comprehensive global regulatory and clinical services and will apply that knowledge to venture capital due diligence.
Regulatory
RCRI will analyze and assess:
- Product classification.
- Indication(s) for use.
- Regulatory strategy.
- Establishment registration.
- Device listings.
- QSR, GMP, GLP compliance.
- Marketing and advertising materials for compliance.
- Competitive product labeling and compliance.
Clinical
RCRI will analyze and assess:
- Trial conduct for regulatory compliance.
- The clinical trial design considering regulatory, reimbursement, and marketing requirements.
- Feasibility of clinical trial enrollment.
- Sites, investigators, and/or key opinion leaders.
- Past and current clinical trials both inside and outside the target market.
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