Services We Offer:
INSIGHT
The RC Insight Group understands that our science must serve people. We understand and value how integrated competitive solutions and critical thinking can help our healthcare partners achieve their business goals to improve product performance and healthcare outcomes.
Every stage of your products’ lifecycle presents opportunities to impact performance and regulatory strategy. Incorporating regulatory and clinical expertise early in the product development planning ensures efficient evaluation and implementation of product market pathways that are both compliant and cost effective, while successfully navigating the complex and highly evolving regulatory landscape.
The RC Insight Group provides a broad spectrum of consulting support, from preclinical to commercialization and beyond. Under the leadership of our regulatory affairs experts, our team will work closely with you and regulatory agencies around the world to promote a compliant, high-quality, and efficient application and submission process.
We leverage our collaborative experience with devices, drugs, and biologics (including combination products) to provide Comprehensive product development and regulatory strategy, drawing on scientific rigor and research excellence. We apply our expertise across multiple key regulatory authorities, countries, and therapeutic areas to successfully address the specific issues that affect each application.
Advise on international regulatory requirements and ensure data generated in support of an application meets these requirements including:
- MDSAP & EU MDR/ IVDR
- Risk Management Planning & Supplier Management
- Clinical Evaluation Report (CER) & Benefit/Risk Determination
- Post Market Clinical Follow Up (PMCF)
- Post Market Surveillance Report (PMSR)
- Periodic Safety Update Report (PSUR)
In addition, we can:
- Serve as Official Correspondent for FDA submissions
- Serve as US Agent with the FDA
- Interact and manage meetings with regulatory agencies to seek advice, agreement, and approval
- Provide regulatory due diligence evaluations of products or corporate acquisitions
Prepare global regulatory and clinical strategy to ensure a holistic approach to clinical trial planning and final commercialization, including:
- Regulatory intelligence and market analysis
- Global regulatory and clinical plan development
- Clinical trial design as well as clinical trial implementation and management
- IDE/IND FDA presub meetings and applications
- 510(k), De Novo, and PMA submissions
- CE Mark Technical File and Dossier compilation
- CB Scheme testing requirements analysis
- Import/export certification
