At Kindeva Drug Delivery, quality is at the core of everything we do. As a top five global combination product CDMO, we have an ongoing commitment to ensure both quality and compliance are built into every step of the drug-device development process, from ideation through post-commercialization — and we have more than a century of success stories to prove it.
We work within Quality by Design (QbD) principles that align with our right-the-first-time mentality. When you combine forces with Kindeva, you’re choosing industry-leading quality and reliability that bolsters the success of your complex combination product.
Our team of innovators has a solid track record of experience and demonstrated competency with both medical device and pharmaceutical requirements from regulatory bodies all over the world, including full Current Good Manufacturing Practice (cGMP) compliance, CFR 210, CFR 211, CFR 820, 21 CFR Part 4, and ICH Q1A through Q10.
01. Customer
- Alignment to customer expectation
02. Leadership
- cGMP focus
- Quality 1st behaviors
03. People
- Data integrity and right-the-first-time
04. Process
- State-of-the-art processes
- Real-time continuous process
05. Improvement
- Proactive signal management
06. Evidence-based decision making
- Risk based CQV driven
07. Relationship management
- Proactive communication
- Transparency
- Partnership
Quality capabilities
Our targeted quality capabilities include but are not limited to: