Key areas of support include:
- Strategic drug development
- Clinical development plans (CDPs)
- Registration strategies
- Optimized exit strategies
- Translational clarity
- GxP compliance strategies
- Due diligence
By leveraging the worldwide capabilities of INC Research, the Strategic Consulting Group provides expertise that blends a global perspective with an understanding of important regional nuances.
Our consultancy is comprised of senior executives from regulatory affairs, clinical research, biostatistics and data management – individuals with expertise gained through hands-on experience as former CEOs and executives from pharma, biotech (both well established and emerging companies), the CRO industry and regulatory agencies. We complement our internal expertise with external thought leader alliances to ensure complete coverage for the entire lifecycle of the product.
Once we have matched our consultancy teams with our customer’s unique challenges, we can provide follow-through by interfacing with INC Research’s global operations. This combination of strategy with tactical execution based on our Trusted Process methodology ensures a comprehensive solution for our customers. Our Strategic Consulting Group offers you timeless advice for timely results.
Global Regulatory Services
We offer regulatory expertise across the entire lifecycle of small molecules, proteins (innovators and biosimilars) and devices. Whether providing operational support or strategic consultancy, our goal is to maximize clients’ potential for success. We understand the importance of time and the value of flawless execution. Regulatory Affairs at INC Research has a global footprint. Staff are located at multiple offices in the US, EU, and Canada. In addition, subject matter experts are located in our offices throughout the world to ensure we maintain a global regulatory umbrella for our clients (e.g., EU countries, Eastern Europe, Asia, India). Although globally distributed, the regulatory groups form one integrated global unit with central oversight from the corporate headquarters in Raleigh, North Carolina. Individuals within the group have substantial hands-on regulatory knowledge gained through successful and diversified experience in large pharma, emerging biotech, CROs, at the FDA and in regulatory forums worldwide.
Services include:
- Worldwide Regulatory Submissions (NDA, BLA, MAA, CTD)
- Regulatory Strategy and Agency Meetings
- Early Development Consultancy
- DSMBs and DRCs Management
- Chemistry Manufacturing and Controls
- Contemporary Regulatory Interpretation
- INDs
- CTAs
For more information on INC Research’s Strategic and Regulatory Consulting services, click here.
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