At the forefront of innovation, our expertise in Combination Products sets us apart. Defined by FDA CFR Part 4, combination products represent a unique intersection of drug, device, and/or biologic elements, each bringing its own set of complexities and regulatory challenges. Navigating this intricate landscape requires a deep understanding of multifaceted regulatory requirements, along with the ability to seamlessly integrate diverse technologies and therapeutic modalities. Our team excels in synthesizing these elements, ensuring that your combination product not only meets rigorous FDA and global standards but also advances the frontier of patient care.
Understanding the criticality of these innovative treatments, we offer unparalleled support in the development and commercialization of combination products. Our approach is rooted in collaboration, leveraging cross-functional expertise in pharmaceuticals, medical devices, and biologics to drive the success of your project. From concept to market, we guide our clients through every step of the process, addressing technical challenges, regulatory hurdles, and market considerations with precision and agility. Whether you’re introducing a new product or enhancing an existing one, our comprehensive services ensure that your combination product achieves its full potential, delivering transformative solutions to those who need them most. Some of the deliverables we can help you with are specified below:
Design Controls
- Design and Development Plan
- User Needs and Stakeholder Needs
- Design Inputs
- Design Outputs
- Design Verification & Design Validation
- Test Method Validation
- Trace Matrix
Risk Management
- Risk Management Plan and Report
- Design Failure Mode Error Analysis (DFMEA)
- Process Failure Mode Error Analysis (PFMEA)
- Use Related Risk Analysis (URRA)
- Product Hazard Analysis (HA)
- Risk Analysis Matrix
- Clinical Risk Benefit Analysis (CRBA)
Design Transfer
- Creation of Device Master Record (DMR)
- IQ/OQ/PQ
- Process Validation
- Mold Approvals
