Global Regulatory MedDev offers extensive support for Combination products throughout their entire lifecycle. Our extensive expertise covers many areas:
1. Product Assessment and Request for Designation (RFD Submissions)
2. Global Regulatory Strategies
3. Quality Systems Development and Support
4. Inspectional Readiness
5. Training for Modified Quality Systems
6. Life Cycle Management and Post-Approval Support
7. Due Diligence Audits / Mergers and Acquisitions 
Combination products refer to therapeutic and diagnostic products that combine drugs, devices, and/or biological products. These innovative products play a crucial role in healthcare by integrating different modalities to enhance patient outcomes.
The U.S. Food and Drug Administration (FDA) oversees combination products, ensuring their safety, efficacy, and regulation compliance.
Here are some key points about combination products:
Combination products are composed of any combination of the following:
- Drug and device
- Biological and device
- Drug and biological
- Drug, device, and biological product
These components are physically, chemically, or otherwise combined or mixed to create a single entity.
Regulatory Oversight:
- The FDA provides guidance, regulations, and rules specific to combination products.
- Manufacturers must navigate the complex landscape of regulations to ensure compliance.
= The Office of Combination Products (OCP) within the FDA oversees these products and provides valuable resources.
Types of Combination Products:
- Examples include drug-eluting stents, drug-coated implants, and diagnostic devices incorporating biological components.
- Each combination product requires a unique approach to regulatory approval and post-market surveillance.
In summary, combination products represent an exciting intersection of medical technologies, and their development and regulation involve collaboration across different disciplines to benefit patients and advance healthcare.