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.
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 […]
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Powering every breath you give: Our world-class Loughborough site
Pulmonary drug delivery is undergoing a period of rapid change. Developers must bring increasingly complex therapies to market while preparing inhalers for the transition to low-Global Warming Potential (GWP) propellant technologies. Success depends on having expertise across formulation, device integration and scalable manufacturing capabilities. Kindeva’s Loughborough, UK facility stands ready for this evolution. Our global […]
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Parenteral capabilities overview
Next-generation biologics and combination products require precision and close coordination between drug delivery technologies and manufacturing execution. Kindeva advances parenteral programs across development and commercial supply by bringing together device expertise, aseptic manufacturing and scalable operations. Why choose Kindeva for your parental program Large-scale sterile fill finish The Bridgeton site supports vial, cartridge and prefilled […]
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Navigating the green revolution: Why next-generation propellants are critical for pMDIs
The imperative to address climate change is reshaping industries worldwide, and pharmaceutical manufacturers are no exception. In respiratory medicine, the spotlight has fallen on pressurized metered-dose inhalers (pMDIs). While crucial for millions of patients, pMDIs harness propellants with a global warming potential (GWP) many times higher than CO2. This significant environmental footprint is a critical […]
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Where the propellants are greener: Inside the MDI facility of the future
As the pharmaceutical industry accelerates toward net-zero goals, inhalation therapies face unique scrutiny. Pressurized metered-dose inhalers (pMDIs) remain vital for millions of patients, yet their reliance on legacy propellants presents a sustainability challenge. To address this, Kindeva has established its UK headquarters and MDI Center of Excellence in Loughborough, a facility purpose-built to lead the […]
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Career journeys blog 4: Grace Guo
In this story, we meet Grace Guo, Manager of Client Portfolio Relationship Management, whose pathway at Kindeva has grown through clear communication, strategic thinking and a strong focus on people.
Learn MoreThe next leap in skin-based drug delivery: How dermal delivery platforms are transforming tomorrows for patients
Skin-based drug delivery is gaining attention as patients and healthcare systems look for treatments that support at-home administration and remove the need for needle-based injections. As this shift accelerates, developers are investing in technologies that improve usability without compromising performance. These platforms are opening new possibilities for therapies that rely on reliable, patient-preferred delivery. A […]
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Webinar | A Bridge to the Future of Aseptic Manufacturing: A Pharma 4.0 Case Study
Growing demand for high-quality sterile fill finish capacity is putting pressure on development timelines and supply programs across the industry. As expectations for Annex 1 alignment, agility and data-driven control rise, partners need facilities designed to keep pace with evolving requirements. In this on-demand webinar, Chad Hafer, Director of Technical Operations, Aseptic Fill Finish at […]
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Career journeys blog 3: Lauren Harrison
In this story, we meet Lauren Harrison, a formulation scientist who began her path as an apprentice and has spent the last decade building a career rooted in curiosity, hands-on learning and collaboration.
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.