Quality
As a global drug delivery CDMO with a rich legacy of experience, we maintain an unwavering commitment to ensuring that quality and compliance are embedded in every step of the drug-device development process, from ideation through post-commercialization. Our investment in state-of-the-art facilities, cutting-edge technologies and advanced analytical capabilities demonstrates our dedication to providing strategic value that extends beyond manufacturing.
Quality: Exceptional by design
We operate within Quality by Design (QbD) principles, ensuring that quality is embedded in every stage of the development and manufacturing process. Our experts have extensive experience in meeting both medical device and pharmaceutical requirements from regulatory bodies worldwide.
Full compliance with current Good Manufacturing Practice (cGMP) guidelines
We maintain full compliance with current Good Manufacturing Practice (cGMP) guidelines, including:
- CFR 210
- CFR 211
- CFR 820
- 21 CFR Part 4
- ICH Q1A through Q10
Understanding our QbD approach
1. Customer
- Alignment to customer expectation
2. Leadership
- cGMP focus
- Quality 1st behaviors
3. People
- Data integrity and right-the-first-time
4. Process
- State-of-the-art processes
- Real-time continuous process
5. Improvement
- Proactive signal management
6. Evidence-based decision making
- Risk based CQV driven
7. Relationship management
- Proactive communication
- Transparency
- Partnership
Quality capabilities
We embed quality into every product and process, aligning with QbD, Six Sigma and Right First Time (RFT) methodologies to ensure exceptional quality from inception.
We provide full compliance with cGMP guidelines and comprehensive support for CMC sections of regulatory submissions, including INDs, European filings, DMFs and ANDAs.
Our Bridgeton facility is designed to achieve complete Annex 1 compliance for sterile drug manufacturing, ensuring the highest standards of sterility assurance.
We leverage advanced automation strategies to optimize your supply chain, minimize risk and enhance production efficiency.
Kindeva utilizes automated measuring equipment to ensure repeatable, reliable and consistent quality throughout the manufacturing process.
With decades of experience navigating international regulatory and quality standards, we facilitate the seamless shipping and sales of combination products worldwide. We hold all necessary ISO certifications, ensuring compliance with global standards.
Our postmarket support services maintain rigorous quality and compliance standards, from product intake through analysis, ensuring the ongoing success of your therapy.
We implement proactive, non-destructive evaluation methods, including X-rays and CT scans, to assess the quality and integrity of products and components.
We prioritize product reliability, exceeding industry standards with a focus on “four and five nines” reliability. Our commitment to quality, combined with Annex 1 compliance for parenteral products, ensures that your product meets the highest expectations for performance and safety.
Our regulatory experience and historical know-how in microneedle technology enable us to prioritize patient comfort and compliance by providing pain-free delivery solutions, addressing the needs of needle-phobic patients.
Backed by over a century of experience, our analytical and testing services encompass every stage of your combination product’s lifecycle, with expanded capabilities in IVBE, functional testing and regulatory support.
Quality resources and insights
Explore our library of resources to learn more about our quality processes and expertise.
Video tour | Explore Kindeva’s US manufacturing network
As a purpose-fueled, people-centric drug delivery CDMO, we are dedicated to advancing programs that help fast-track healthier tomorrows. Our US facilities play a vital role in delivering this commitment, providing specialized environments, technical depth and operational excellence that extend beyond manufacturing. Our US sites are strategically located and designed to support complex drug delivery programs […]
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Explore our world-class sterile injectable facility in Bridgeton, Missouri | Video tour
Spanning over 155,000 sq. ft. of dedicated aseptic operations space, our Bridgeton, MO facility brings together leading expertise, advanced automation and Annex 1-compliant isolator technology to help support growing global demand for sterile injectables. Designed to deliver excellence from floor to ceiling, Bridgeton seamlessly connects development and delivery through flexible fill finish infrastructure that helps […]
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PharmaSource podcast with Tommy Schornak
Today’s pharmaceutical companies must manage tight timelines and high demand for products, as well as shifting regulatory requirements and an increasingly complex global supply chain. How can contract development and manufacturing organizations (CDMOs) rise to this challenge and provide the support they need? In this podcast with PharmaSource, Tommy Shornak, Senior Vice President, Sterile Injectables, […]
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The bridge to uncompromising fill finish precision
Sterile fill finish is a sequence of tightly connected control points, where performance at each stage directly influences quality, timelines and patient safety. Bridgeton is designed to deliver control at every step of the fill finish journey. Our 155,000 sq. ft. aseptic facility combines advanced automation, gloveless isolator technology and structured process design to reduce […]
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The bridge to the future of sterile injectables
Access a sterile fill finish solution designed to help your product progress from formulation through commercial scale with greater confidence and control. Having invested over $200M in our purpose-built, Annex 1-aligned facility in Bridgeton, MO, we bring together the infrastructure, expertise and control needed to accelerate your path to market. From early development through to […]
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Your bridge to commercial sterile manufacturing
Sterile fill finish has changed. Annex 1 compliance and data transparency are no longer future considerations; they are the baseline. At the same time, programs are expected to move faster, scale seamlessly and maintain absolute control from the first clinical batch through commercial supply. Siloed models cannot keep up with the pace and control required […]
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Manufacturing more sustainable tomorrows for pulmonary care
The shift to more sustainable inhalers is gaining pace. As pressure grows to reduce their environmental impact, low-Global Warming Potential (GWP) propellants are becoming an important part of the future of metered dose inhaler (MDI) development. In this infographic, we explore the trends shaping that transition, and share how Kindeva is helping partners prepare for […]
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Parenteral precision: Annex 1-ready sterile fill finish by design
Parenteral precision is a blog series exploring the controls, technologies and design decisions that shape modern parenteral manufacturing. Each article looks at one capability through a practical lens: what it is, how it works, who it supports and why it matters. This first blog focuses on Annex 1-ready sterile fill finish. As the European Union […]
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Beyond the bench: Aerosol analysis and the physics of MDI performance
Modern drug delivery is built on an architecture of precision and predictability to ensure patient safety. Behind every successful inhalation therapy lies a methodical application of analytical science that characterizes the behavior of complex aerosol systems. In this Beyond the bench blog, we examine how this analytical backbone supports the development of pressurized metered-dose inhalers […]
Learn MoreLet’s transform tomorrow together
Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.