Navigating drug-device combination products through the FDA and into production
What does Edaphy offer?
Expertise in relevant FDA regulations such as CFR 21 Part 4
Development knowledge and the right supply chain of vendors for testing, manufacturing, and packaging of combination products
Quality Management Systems (QMS) that efficiently address combinations of drug, device, and software requirements
Steps of the journey
The life cycle of a combination product includes various phases. At each step we can provide help: Strategic planning, FDA interactions, design, engineering, QMS development, manufacturing and packaging, verification & validation, submission compilation, quality management, etc.
Strategic Planning and FDA Interactions. Align product, business, and regulatory objectives. Edaphy understands how essential product performance drives FDA requirements and wise choices can decrease your burden and accelerate time to market. We facilitate productice interactions with the FDA throughout, from pre-IND meetings to regulatory submissions and post-market amendments.
Design, Development, Implementation, Testing, and Certification. Combination products require a multidisciplinary team. Our in-house experts are supported by a strategic network of manufacturers, analytical laboratories, certification testing services, packagers, etc.
Quality Management Compliance. Whether you already have a QMS for combination products or you are starting from scratch, Edaphy’s team can help. Reduce your time to quality compliance by leveraging our structured development processes and documentation templates. We can help with ISO13485, 21CFR§820, and Part 11 electronic records compliance as well as develop acceptance criteria for your quality limits.